You have not been assigned a username and password. UPDATE: Potential Concerns with NuVasive Precice Devices These technologies include neuromonitoring, global alignment, rod bending, radiation reduction, imaging, and navigation. Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill. Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology. An integrated technology platform to enable better spine surgery. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. At NuVasive, we aspire to change a patients life every minute. $1,299.99. Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. COCCYX ZONE OF SPINE FOR. Based in San Diego, NuVasive acquired Simplify Medical earlier this year with a $150 million upfront payment to expand its cervical spine technology portfolio. Check out The Better Way Back, a free patient support program for those suffering from a spinal condition. Home | NuVasive At NuVasive, we transform surgery, advanced care, and change lives. Forward-Looking Statements As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to help transform spine surgery, and ultimately change the lives of your patients. Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070. PDF NVM5 Computer-Assisted Rod Bending Journal of Neurosurgery Spine. Three New Biologic Products for Spine Surgery or more while undergoing treatment, and. Expected delivery: 3 weeks. PDF User Manual - Nuwave Cpap You should always talk to your healthcare professional for diagnosis and treatment. obtained from Document Control, or a reference copy may be viewed on the NuVasive Network Server. Open the catalog to page 2 What is causing my pain? These two parts work in conjunction to allow the spine to bend, twist, and also provide shock absorption. Polini A, Pisignano D, Parodi M, et al. 789 0 obj <> endobj PDF NuVasive, Incorporated September 26, 2019 Mr. Mark Job Responsible /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. Innovation in Musculoskeletal Solutions | Globus Medical Hear from Doug Bireley, Vice President of Global Product Marketing, product leadership, and spine surgeons across the globe. xZrJ]e7,[Uv%d|7@$$! In this chapter, we focus on the steps of the technique, with particular attention to the nu- ances that contribute to a successful outcome. We are excited about the opportunities this acquisition creates as we work to optimize the surgeon experience, advance the standard of care, and create value for shareholders.. The NuVasive CPD program focuses on surgeon development through the design and delivery of innovative clinical education programs. PDF NUVASIVE' 1 Nu Vasive Sage Lateral Plate System '4 Price: $5.00 per kit. To learn more, visit www.simplifymedical.com. Based on review of publicly available materials at the time of this release. z0XF BEF1[ En>0XKO&`yNq-L 8)(T=f $749.00. The SRS-Schwab adult spinal deformity classification: Surgical efficiency. Ensure patients with a Precice device continue to receive appropriate follow-up monitoring. Prices (minimum order quantity 144 pieces)144 pieces - 2,75288 pieces - 2,50more than 500 pieces - pleasecontact usfor a new quote. This service located at Oisto.com is a website owned and operated by Oisto. The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts. hbbd``b`I3@R $eL :X] BDLv ^e a$@@ He`bd^d100H xl Efficacy of a standalone microporous ceramic vs. autograft in instrumented posterolateral spinal fusion; a multicenter, randomized, intra-patient controlled, non-inferiority trial. Get your money back!. NuVasive provides patient support and surgeon education. The dial-in numbers are 1-800-954-0604 for domestic callers and 1-312-281-1210 for international callers. Photos are for illustration purposes only and may not depict the exact item. Expected delivery: 3 weeks. If the item is subject to FDA regulation, seller must verify your status as an authorized purchaser of this item before shipping of the item. The acquisition of Simplify Medical advances our previously communicated long-term growth strategy by both expanding, and further distinguishing, our portfolio with industry-leading innovation, said J. Christopher Barry, chief executive officer of NuVasive. Website www.nuvasive.com. By using modern education principles, competency-based curriculum, and multi-modal learning pathways, the CPD team and its dedicated surgeon faculty provide an unparalleled learning experience for surgeons and their staff around the globe. The disc is comprised of two parts, a tough and fibrous outer layer (annulus fibrosis), and a soft, gelatinous center (nucleus pulposus). The contents of this Site, including but not limited to the text and images herein and their arrangements, unless otherwise noted, are the copyrighted material of Oisto. Excluding VAT and shipping. DLA Piper is serving as NuVasives legal counsel. All products | NuVasive Webshop 8050015: NuVasive NVM5 EMG Needle Module. Plenty of storage and clever organisation for life on the go, Store a 15.6" laptop in the dedicated compartment padded with EVA Impact Foam for extra protection, Spacious main compartment with structured slip pockets for a tablet, For organising a portable charger, cables and accessories, Lightweight collapsible pitchfork made of high-quality ABS plastic, Equipped with a magnetic ball marker with Nuvasive logo-doming, Kobaldeck playing cards are of absolute top quality, Back of cards and box are printed with Nuvasive logo, Receptacles for Europe, USA/Japan, Australia/China, All international security-relevant standards and norms, Keeps your drinks cold for 8 hours and hot for 5, Height 25cm, diameter 7cm - Volume: 500 ml, Ergonomic design provides a comfortable fit for your ears, Handy pocket-size power booster - 5000mah. 8050015: NuVasive NVM5 EMG Needle ModuleExpired NuVasive NuVasive. Learn how the use of Attrax Putty in Modulus XLIF cages resulted in a 97.8% rate of bone bridging5 from Drs. PDF eXtreme - SMISS NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. Login - NuVasive Company Store - Direct EDJE Excluding VAT and shipping. JavaScript seems to be disabled in your browser. A live webcast of the conference call will be available online from the Investor Relations page of the Companys website atwww.nuvasive.com. The cervical segment of the global spine market represents a $2.6 billion opportunity, and the Company is well-positioned to expand its reach with the addition of the Simplify Disc to its C360 portfolio. Reimagine cervical spine surgery. Read the press release In this list are all medical devices registered by the ministry of health that are produced by the manufacturer NUVASIVE, INC. Name: NUVASIVE, INC. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasives cervical portfolio in the market. On April 5, 2021, NuVasive posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices. NUVASIVE USA: 'NNUVASIVE' NuVasive, Inc. ~L ~ o 7475 Lusk Blvd. NuVasive is headquartered in San Diego, California, the US. Expected delivery: 3 weeks. All rights reserved. San Diego, California 92121 Re: K210214 Trade/Device Name: NuVasive Modulus Expandable Posterior Lumbar MOD-EX PL Interbody System Regulation Number: 21 CFR 888.3080 Regulation Name: Intervertebral body fusion device Regulatory Class: Class II Product Code: MAX Today, the FDA is providing updated information and recommendations on the titanium-based Precice devices. NuVasive introduces new Reline 3D posterior fixation system The potential combination would accelerate consolidation in the spine surgery market, where smaller players are turning to dealmaking to compete against the likes of Johnson & Johnson (JNJ.N), Medtronic Plc (MDT.N) and Zimmer Biomet Holdings Inc (ZBH.N). Reline 3D, which is an extension to the NuVasive's Reline system, is part of the firm's comprehensive spine fixation portfolio that includes Reline Open, Reline MAS, Reline Trauma and Reline Small Stature. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. All quotes delayed a minimum of 15 minutes. NuVasive provides patient support and surgeon education. gtag('config', 'G-XBG07ECKJ5'); BOLTS FOR SMALL CAGE COROENT INTERLOCK NUVASIVE, CERVICAL DISC PROSTHESIS CERPASS NUVASIVE, CONNECTOR AND NUT CLOSURE STERILE - VUEPOINT II, COROENT CAGE SMALL SCREW INTERLOCK NUVASIVE, COROENT LARGE OBLIQUE STERILE - CAGE INTERSOMATICO, COROENT SMALL INTERLOCK II - CAGE INTERBODY, COROENT XL TITANIUM BARREN - CAGE INTERBODY, DYNAMIC STIMULATION AND INLINE CLIP APPLICATOR, HOOK AND NUT CLOSURE STERILE - VUEPOINT II, LIVES FOR LATERAL PLATE NEXT GEN DECADE NUVASIVE, NV M5 XLIF KIT WIRE KIRSCHNER AND DILATOR, SCREWS E NUT CLOSURE STERILE - VUEPOINT II, STAPLE FOR LATERAL PLATE NEXT GEN DECADE NUVASIVE, SYSTEM COROENT XL STERILE - CAGE INTERBODY, THE PAS-II PEDICLE INSULATED SYSTEM ACCESS, Complete classification of medical devices. 18 0 obj << /Filter /FlateDecode /Length 19 0 R >> stream The following important factors, among others, could cause actual results to differ materially from those set forth in the forward-looking statements: the loss of key employees; the risk that the businesses will not be integrated successfully; unexpected variations in market growth and demand for the combined companys products and technologies; and the risk that benefits from the acquisition may not be fully realized or may take longer to realize than expected. Prices(minimum order quantity 25 pieces)25 - 49 pieces - 17,7550 - 99 pieces - 15,90100 - 150 pieces - 14,70more than 150 pieces - please contact us for a new quote. Unhappy? In this video, they review the findings around improved patient outcomes and reduced economic burden when using these products together. 2Data on file. var tpl_folder = "https://www.medicaldevices24.com/public/tpl"; Excluding VAT and shipping. NuVasive is developing the operating room of the future. About NuVasive Simplify Medical is a medical device company focused on cervical spinal disc arthroplasty, using innovative, MRI-compatible materials designed to optimize diagnostic imaging and decrease the need for ionizing radiation. The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. The Attrax ceramic surface has unique microstructure and microporosity that are optimized for bone formation. Prices (minimum order quantity 50 pieces)50 - 99 pieces - 8.40100- 250 pieces - 7.50more than 250pieces - pleasecontact usfor a new quote. 1997-2023 WestCMR. Disc space preparation 5. (This story corrected name of Globus Medical in the headline from Global Medical). Combining the Simplify Disc with NuVasives C360 portfolio will enable us to provide surgeons with world-class cervical technology, regardless of their preferred procedural approach. You don't have to face this journey alone. The cervical segment of the global spine market represents a $2.6 billion opportunity, and the Company is well-positioned to expand its reach with the addition of the Simplify Disc to . PDF NuVasive, Incorporated Ms. Daniela Mahan, Esq., RAC 7475 Lusk Blvd Lehr MA, Oner CF, Delawi D, et al. Intelligently designed for fusion. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made. NuVasive offers solutions to alleviate patient symptoms. Information you read on this website cannot replace the relationship that you have with your healthcare professional. NuVasive Launches Modulus ALIF. Precice devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism. Spine 2020;45(14):944-51. Three New Biologic Products for Spine Surgery. List of devices made by the manufacturer NUVASIVE, INC. Through our shared mindset calledThe Cheetah Way, we show up every day united and committed to do just that. NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasives results to differ materially from historical results or those expressed or implied by such forward-looking statements. The San Diego, CA-based company said the RMM incorporates extremely low-profile modular implants and advanced system instrumentation to address alignment and potentially reduce . Prices excluding VAT and shipping. 1 Terran J, Schwab F, Shaffrey CI, et al. Its shares are down 2% year-to-date, compared to a 10% rise in the shares of Globus Medical. Provide health care providers and patients access to an adequate supply of titanium-based Precice devices. Alignment Matters . 4. D. Device Description The NuVasive Sage Lateral Plate System is an anterior/anterolateral plate system that may be used in the thoracic, lumbar, and sacral spine (TI-SI). Reuters, the news and media division of Thomson Reuters, is the worlds largest multimedia news provider, reaching billions of people worldwide every day. NuVasive is the fastest growing, full-line spine company. NuVasive is developing the operating room of the future. Adhering to the three core principles of Advanced Materials ScienceSurface, Structure, and ImagingNuVasive has pioneered design and manufacturing methods that combine the inherent benefits of porosity with the advantageous material properties of PEEK and titanium to create implants intelligently designed for fusion. The materials on this website are for your general educational information only. if( $robots ) : ?> PDF NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory Sign in to add this product to your favorites! Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. Expected delivery: 3 weeks. Prices (minimum order quantity 125 pieces)125 - 249- 3,95250 - 500 - 2,90more than 500pieces - pleasecontact usfor a new quote. Height 25cm, diameter 7cm - Volume: 500 ml. PDF Document Title: Visual and Cosmetic Standards for Manufacturing Telephone 1 858 9091800. NUVASIVE: 2012022 - WestCMR Alignment. Please close the page and access the Company Store via Okta. This is why we show up every day, united and committed to our vision. Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion? Expected delivery: 2 weeks. WestCMR and WestCMR Surgical Surplus Marketplace are trademarks of West Coast Medical Resources, LLC. At this time, the overall benefits of the devices outweigh the known risks for on-label use with the updated labeling, compared to alternative treatments. All Trademarks & Logos belong to their respective owners. 50 - 99 pieces - 8,75. Voluntary reports can be submitted through, Device manufacturers and user facilities must comply with the applicable, Health care personnel employed by facilities that are subject to the. Product Code: LLZ C. Predicate Devices The subject NuVasive NuvaLine is substantially equivalent to the primary predicate NuVasive NuvaLine Mobile App (K162647) and additional reference devices NuVasive NVM5 System (K152942), Nemaris Surgimap 2.0 (K141669), and NucleusHealth Nucleus Image Mangement System (K171130). NUVASIVE: 2012022 SKU# 2012022-WE1. Osteocel is human tissue donated specifically for human clinical use. The three essential biologic mechanisms involved in complete bone grafts include osteoconduction (a scaffold for the reparative growth of the natural bone), osteoinduction (signals encouraging undifferentiated cells to become active osteoblasts), and osteogenesis (living bone cells in the graft material contribute to bone remodeling). Address 7475 Lusk Blvd, San Diego, California, 92121. 2.0 Scope December 1, 2021 The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics' Precice devices made from. The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with NuVasive Precice devices. The Companys less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. D. Device Description San Diego, CA 92121 PCM THE CERVICAL DISC SYSTEM INSTRUCTIONS FOR USE Rx Only GRAPHICAL SYMBOLS Read Instructions Before Use Single Use Only Catalog Number Lot Number STLE RSterile by Irradiation Non-Sterile, Sterilize by Steam before Use Manufacturer Use By HOW SUPPLIED The .gov means its official.Federal government websites often end in .gov or .mil. Expected delivery: 2 weeks. The FDA continues to work with NuVasive to: The FDA will continue to keep health care providers and the public informed as new or additional information becomes available. (Top row): NuVasive DBM putty and gel and NuVasive amniotic membrane DS (Bottom Row): Traditional bone allograft and DBM fibers / Courtesy of NuVasive, Inc. NuVasive, Inc. has announced U.S. commercial launch of three new biologics . If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE). Tell us something about it and help others to make the right decision, We use UPS, Fedex, USPS and our sellers ship quickly and securely, Customer satisfaction is our top priority, we are not happy until you are happy. NuVasive, Incorporated Olga Lewis Director, Regulatory Affairs 7475 Lusk Blvd. Clinical benefits ALIF Anterior approaches, such as in ALIF, allow access to the discs at the front of the spine and do not require muscle stripping as in posterior approaches. nuvasive product catalog pdf %%EOF NuVasive has developed the Reline 3D system to offer simultaneous and three-dimensional deformity correction through a simplified procedure. Potential Biocompatibility Concerns with NuVasive Specialized NuVasive offers solutions to alleviate patient symptoms. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 66,7050 - 100 pieces - 63,10more than 100pieces - pleasecontact usfor a new quote. As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to change patient lives. Information you read on this website cannot replace the relationship that you have with your healthcare professional. Information you read on this website cannot replace the relationship that you have with your healthcare professional. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. The Companys comprehensive procedural portfolio includes surgical access instruments, spinal implants, fixation systems, biologics, software for surgical planning, navigation and imaging solutions, magnetically adjustable implant systems for spine and orthopedics, and intraoperative neuromonitoring technology and service offerings. Additional risks and uncertainties that may affect future results are described in NuVasives news releases and periodic filings with the Securities and Exchange Commission. NuVasive plans to announce tomorrow its financial results for the fourth quarter and full year ended Dec. 31, 2020. 888 0 obj <>stream Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. At NuVasive, we transform surgery, advanced care, and change lives. Prices excluding VAT and shipping. NuVasive Acquires Simplify Medical - NuVasive Quantity: NuVasive provides patient support and surgeon education. List of devices made by the manufacturer NUVASIVE, INC. BOX8-1Five Key Steps for Performing the XLIF Procedure 1. Nov 15 (Reuters) - Globus Medical Inc (GMED.N) has approached NuVasive Inc (NUVA.O), a U.S. manufacturer of equipment for minimally invasive spine surgery with a market value of $3 billion, with an acquisition offer, people familiar with the matter said. Variation of the bone forming ability with the physicochemical properties of calcium phosphate bone substitutes. As NuVasive continues to investigate the root cause of issues with stainless steel-based Precice devices, the company is also looking into how those issues may relate to titanium-based devices. Globus Medical eyes acquisition of spinal implant maker NuVasive %PDF-1.5 % Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. NuVasive is now able to address all key segments of the cervical spine by offering comprehensive, procedurally integrated solutions across anterior cervical discectomy and fusion (ACDF), posterior cervical fusion (PCF), and cTDR procedures. Based on review of publicly available materials at the time of this release. NuVasives scale and global commercial channels will greatly accelerate the ability to bring the Simplify Disc to more surgeons and patients around the world.. Reuters provides business, financial, national and international news to professionals via desktop terminals, the world's media organizations, industry events and directly to consumers. Propel DBM Fibers and Propel DBM Sponge are 100% bone and are intended for homologous use in the repair, replacement, or reconstruction of skeletal defects. Clarification that the device is intended for use only in patients 18 years and older, That patients should weigh 50 lbs. NuVasive has struggled with the impact that healthcare staffing shortages and weaker demand for elective surgery have had on its sales since the onset of the COVID-19 pandemic. Returns are simple. For the best experience on our site, be sure to turn on Javascript in your browser. Malone, H., Mundis, G. M., Jr., Collier, M, et al. 1.0 Purpose. Peer-to-peer discussion between Drs. Precice devices are implants intended for patients 18 years and over, to lengthen the limb, shorten or compress the limb, or transport segments of long bones. NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. We do not practice medicine or provide medical services or advice as a part of this website. ET / 1:30 p.m. PT to discuss these results. SAN DIEGO February 24, 2021 NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally integrated solutions, today announced that it has acquired Simplify Medical, a privately held company and developer of the Simplify Cervical Artificial Disc (Simplify Disc) for cervical total disc replacement (cTDR).
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