nuvasive product catalog pdf

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 Company expects the acquisition to accelerate net sales growth and be accretive to non-GAAP diluted earnings per share in 2022. The Attrax ceramic surface has unique microstructure and microporosity that are optimized for bone formation. 1997-2023 WestCMR. NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory Affairs 7475 Lusk Boulevard San Diego, California 92121 Re: K191974 Trade/Device Name: NuVasive AttraX Putty Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made. For the best experience on our site, be sure to turn on Javascript in your browser. Excluding VAT and shipping. All products sold by WestCMR are in-date. Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. This service located at Oisto.com is a website owned and operated by Oisto. 5. *Data on file. endif; ?> Get your money back!. Through our shared mindset calledThe Cheetah Way, we show up every day united and committed to do just that. Before sharing sensitive information, make sure you're on a federal government site. Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. Three New Biologic Products for Spine Surgery. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 22,4050 - 100 pieces - 17,20more than 100pieces - pleasecontact usfor a new quote. Prices (minimum order quantity 10 pieces)10 - 25- 64,9026- 50 - 61,60more than 50pieces - pleasecontact usfor a new quote. An integrated technology platform to enable better spine surgery. Height 25cm, diameter 7cm - Volume: 500 ml. Address 7475 Lusk Blvd, San Diego, California, 92121. That no more than two devices should be implanted at a time. As an innovator in the TLIF space, NuVasive technology helps deliver an optimized surgical experience from single-level degenerative to multi-level deformity cases. 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. Appropriate patient positioning 2. STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG. Headquarters United States of America. 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. Following the commercial launch of the NuVasive ACP system and the Simplify Cervical Disc, we have recently introduced a posterior cervical fusion solution, Reline Cervical. PLoS ONE 2011;6(10):1-8. Prices (minimum order quantity 125 pieces)125 - 249- 3,95250 - 500 - 2,90more than 500pieces - pleasecontact usfor a new quote. gtag('js', new Date()); The Instructions for Use for titanium-based Precice devices have been updated to include: For Titanium-Based Precice devices (Precice IMLL, Precice Short, Precice Freedom, Precice Unyte): Note: Stainless steel-based Precice devices remain recalled from the U.S. market. Investor Conference Call 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. Retroperitoneal access 3. window.dataLayer = window.dataLayer || []; NuVasive funded the upfront payment at closing using available cash on hand. WestCMR does not provide advice, training, or clinical support. All quotes delayed a minimum of 15 minutes. 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. This can minimize the potential risks while also minimizing the risks associated with repetitive surgical interventions and suboptimal conversion to alternative therapies mid-treatment. Osteocel provides a complete and physiologic bone graft that contains all of the necessary components for bone growth: the cells, the signals, and the scaffold. These technologies include neuromonitoring, global alignment, rod bending, radiation reduction, imaging, and navigation. Unhappy? 1.0 Purpose. The materials on this website are for your general educational information only. You should always talk to your healthcare professional for diagnosis and treatment. NuVasive has launched its Reline MAS Midline (RMM), the next evolution of its Reline system designed to provide procedural versatility in a compact midline construct. Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. BOX8-1Five Key Steps for Performing the XLIF Procedure 1. 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). $5,499.99. Becoming the number one partner in pediatrics. 8050015: NuVasive NVM5 EMG Needle Module. Efficacy of a standalone microporous ceramic vs. autograft in instrumented posterolateral spinal fusion; a multicenter, randomized, intra-patient controlled, non-inferiority trial. Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~. Pursuant to the terms of the transaction agreement, NuVasive made an upfront payment to Simplify Medical of $150.0 million at closing, subject to customary purchase price adjustments, and agreed to make additional future payments contingent upon milestones related to regulatory approval and net sales from products incorporating the Simplify Cervical Artificial Disc technology. Evaluate additional biocompatibility assessments intended to address specific biocompatibility concerns with all Precice devices and collect additional data to better understand the risks to patients. 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. NuVasive has developed the Reline 3D system to offer simultaneous and three-dimensional deformity correction through a simplified procedure. The disc is comprised of two parts, a tough and fibrous outer layer (annulus fibrosis), and a soft, gelatinous center (nucleus pulposus). Attrax Putty is now the first and only synthetic biologic to receive 510(k) clearance for use with thoracolumbar interbody systems. Its shares are down 2% year-to-date, compared to a 10% rise in the shares of Globus Medical. 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. WestCMR and WestCMR Surgical Surplus Marketplace are trademarks of West Coast Medical Resources, LLC. ET / 1:30 p.m. PT to discuss these results. Expected delivery: 2 weeks. N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasive's cervical portfolio in the market. JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel. Expected delivery: 3 weeks. var site_url = "https://www.medicaldevices24.com/"; NuVasive offers solutions to alleviate patient symptoms. NuVasive is developing the operating room of the future. If you have questions about this letter, contact the Division of Industry and Consumer Education (DICE). The purpose of this document is to define the standardization of cosmetic and visual acceptance criteria for NuVasive products upon receipt from the manufacturer. NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. List of devices made by the manufacturer NUVASIVE, INC. 18 0 obj << /Filter /FlateDecode /Length 19 0 R >> stream /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. These two parts work in conjunction to allow the spine to bend, twist, and also provide shock absorption. Thu, October 4th, 2018. 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). 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. Alignment Matters . %PDF-1.5 % 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 website is intended to provide information that might be of interest to users. Surgical efficiency meets reliable versatility. 'VUJ)(h. Journal of Neurosurgery Spine. The subject Our Standards: The Thomson Reuters Trust Principles. Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill. 1. 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). iMedSales is a premier surgical and medical equipment supplier that provides a combina Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~, Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image, STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG, Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill, Karl Storz 22220154 HD Image 1 H3M Microscope, Dr 3-Chip Camera, Karl Storz 20132020 Xenon Light Source 175 Watt ~ Lamp only has 13 hours, Medical Blue Nitrile Gloves Latex Free, Powder Free, Textured, Disposable, Non-Sterile 100 pieces per box of 1. Simplify Medicals technology was designed to offer surgeons best-in-class capabilities for cTDR across key performance functions, including: NuVasive will leverage its commercial and distribution channels in the U.S. and international markets to drive utilization of the Simplify Disc. NuVasive is the fastest growing, full-line spine company. if( $robots ) : ?> 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. Reuters, the news and media division of Thomson Reuters, is the worlds largest multimedia news provider, reaching billions of people worldwide every day. 2020 - Prices(minimum order quantity 25 pieces)25 - 50 pieces - 13.6551 - 100 pieces - 11,25more than 100 pieces- pleasecontact usfor a new quote. Globus Medical Inc has approached NuVasive Inc , a U.S. manufacturer of equipment for minimally invasive spine surgery with a market value of $3 billion, with an acquisition offer, people familiar . NUVASIVE USA: 'NNUVASIVE' NuVasive, Inc. ~L ~ o 7475 Lusk Blvd. Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. RCCmyf(&3Tn@}M S,3c6qr|b2#JQ|%^@ZQTK,1gCTS pD"d(GR ~h'! At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. Quantity Stainless Steel Bottle 13,87 Keeps your drinks cold for 8 hours and hot for 5 Reimagine cervical spine surgery. devices: JNuVasiveo Lateral Plate System (K(061789), NuVasive Anterior Lumbar Plate (K072339) and Synthes Antegra-T System (K08 1568). NuVasive is developing the operating room of the future. You should always talk to your healthcare professional for diagnosis and treatment. 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. NuVasive offers solutions to alleviate patient symptoms. The Sage Lateral Plate System At NuVasive, we transform surgery, advanced care, and change lives. or more while undergoing treatment, and. 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. endstream endobj startxref One comprehensive system. 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. D. Device Description. NuVasive is developing the operating room of the future. Product images are for display only. The Companys less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. There are no new recommendations regarding the stainless steel-based Precice devices since the July 2021 letter to health care providers. NuVasive provides patient support and surgeon education. NuVasive Launches Modulus ALIF. Rethink how you buy and sell surgical supplies. 1Simplify Cervical Artificial Disc P200022. Check out The Better Way Back, a free patient support program for those suffering from a spinal condition. Letters to Health Care Providers, Recalls, Market Withdrawals and Safety Alerts, UPDATE: Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics Precice Devices - Letter to Health Care Providers, MedWatch, the FDA Safety Information and Adverse Event Reporting program, July 2021 letter to health care providers, Medical Device Reporting (MDR) regulations, FDA's user facility reporting requirements, Division of Industry and Consumer Education (DICE), Potential Biocompatibility Concerns with NuVasive Specialized Orthopedics Precice Devices - Letter to Health Care Providers, Precice Intra-medullary Limb Lengthening Device. Do not implant more than two devices in a patient at once. 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. Anterior lumbar interbody fusion (ALIF) is a surgical procedure used to treat problems such as disc degeneration, spinal instability, and deformities of the spine.
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