function gtag(){dataLayer.push(arguments);} 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 4. 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). Bone grafting is a surgical technique that involves implanting a bone substitute or extender to help the body achieve spinal fusion. Alignment. Returns are simple. multi-level pathologies. var tpl_folder = "https://www.medicaldevices24.com/public/tpl"; That no more than two devices should be implanted at a time. Journal of Neurosurgery Spine. Expected delivery: 3 weeks. NuVasive provides patient support and surgeon education. The Company will hold a conference call tomorrow, Feb. 25, 2021, at 4:30 p.m. We do not practice medicine or provide medical services or advice as a part of this website. NuVasive is a medical device company that develops, manufactures, sells, and provides integrated solutions for spine surgery. Excluding VAT and shipping. 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). combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531- The subject var site_url = "https://www.medicaldevices24.com/"; You have not been assigned a username and password. Get your money back!. Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. The materials on this website are for your general educational information only. z0XF BEF1[ En>0XKO&`yNq-L 8)(T=f Prices(minimum order quantity 25 pieces)25 - 50 pieces - 13.6551 - 100 pieces - 11,25more than 100 pieces- pleasecontact usfor a new quote. Hear from Doug Bireley, Vice President of Global Product Marketing, product leadership, and spine surgeons across the globe. 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. Transaction Details Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. Additional risks and uncertainties that may affect future results are described in NuVasives news releases and periodic filings with the Securities and Exchange Commission. This is why we show up every day, united and committed to our vision. Contraindications Discontinue use of NUWAVE if the user develops skin irritation such as acne or a rash around the mask contact area. Becoming the number one partner in pediatrics. $5,499.99. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. Our Standards: The Thomson Reuters Trust Principles. Propel DBM Putty and Gel serve as a bone graft extender (extremities, spine, pelvis) and bone void filler of the extremities and pelvis. NUVASIVE: 2012022 SKU# 2012022-WE1. NV Dynamic Stimulation Clip and Inline Activator. Retroperitoneal access 3. List of devices made by the manufacturer NUVASIVE, INC. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 22,4050 - 100 pieces - 17,20more than 100pieces - pleasecontact usfor a new quote. Through our shared mindset calledThe Cheetah Way, we show up every day united and committed to do just that. We believe in the importance of preoperative decision-making and support toolsinformed by data and clinical experiencepaired with novel, intraoperative tools to execute a surgeon-specific plan. 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. 809 0 obj <>/Filter/FlateDecode/ID[]/Index[789 100]/Info 788 0 R/Length 99/Prev 1608803/Root 790 0 R/Size 889/Type/XRef/W[1 2 1]>>stream The .gov means its official.Federal government websites often end in .gov or .mil. 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. Rethink how you buy and sell surgical supplies. NuVasives scale and global commercial channels will greatly accelerate the ability to bring the Simplify Disc to more surgeons and patients around the world.. 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 . Clarification that the device is intended for use only in patients 18 years and older, That patients should weigh 50 lbs. DLA Piper is serving as NuVasives legal counsel. It offers solutions for a range of conditions such as degenerative disc disease, lumbar spinal stenosis, degenerative spondylolisthesis, cervical disc degeneration, etc. NuVasive is translating nearly 20 years of leadership in spine care into innovative solutions for the pediatric market. In an effort to evolve the standard of care for early-onset scoliosis (EOS) and adolescent deformity patients, we have invested in a comprehensive product portfolio that introduces surgical efficiencies and optimized implant constructs, and we remain committed to supporting the progression of clinical education and scientific research in this space. or more while undergoing treatment, and. 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). 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. Polini A, Pisignano D, Parodi M, et al. Osteocel is human tissue donated specifically for human clinical use. In a single expandable platform, Pulse integrates multiple enabling technologies to improve workflow, reduce variability, and increase the reproducibility of surgical outcomes. 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. The integration of XLIF, XALIF, and XFixation into a single platform enables surgeons to treat a patient without repositioning, which may reduce patient time under anesthesia and hospital costs. In this chapter, we focus on the steps of the technique, with particular attention to the nu- ances that contribute to a successful outcome. $650.00. NuVasive provides patient support and surgeon education. Information you read on this website cannot replace the relationship that you have with your healthcare professional. The U.S. Food and Drug Administration (FDA) continues to monitor potential biocompatibility concerns associated with NuVasive Specialized Orthopedics Precice devices made from stainless steel and titanium. The device is currently being evaluated in a separate IDE study in the U.S. for 2-level indications, pending FDA approval. NuVasive, Inc. (NASDAQ: NUVA) is the leader in spine technology innovation, with a mission to transform surgery, advance care, and change lives. Reimagine cervical spine surgery. An integrated technology platform to enable better spine surgery. Bone Preparation & Cement Application Kits, Balloon Dilatation Catheters Insertion Kits, Skip to the beginning of the images gallery. 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 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. Quantity Stainless Steel Bottle 13,87 Keeps your drinks cold for 8 hours and hot for 5 PLoS ONE 2011;6(10):1-8. Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. As of date of publication, March 2017; data on file. The Sage Lateral Plate System gtag('js', new Date()); 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 offers solutions to alleviate patient symptoms. D. Device Description. All products sold by WestCMR are in-date. NuVasive offers solutions to alleviate patient symptoms. This reflects the technologys favorable growth and margin profile, combined with NuVasives substantial commercial capability and C360 portfolio integration. N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! 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. The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with NuVasive Precice devices. NuVasive offers solutions to alleviate patient symptoms. Price: $5.00 per kit. All rights reserved. Biomater Sci 2018;6:136-45. The X360 System is a comprehensive approach to lateral single-position surgery powered by Surgical Intelligence, an ecosystem of technologies enabling safer, faster, smarter surgery. NuVasives public filings with the Securities and Exchange Commission are available at www.sec.gov. if( $robots ) : ?> hb```b````e`ad@ A(GcG!O HW7o.[S.8{bZx{f(*m(!$ d9>k=ggx rM},(qS>gz}":IHH]1s1@lL j,l l@6kzGkFGkfTt4E# `(AokavH8XVh|Pi\P(d. Prices excluding VAT and shipping. Additional predicates include: NuVasive Modulus XLIF Interbody System (K163230/K192760), NuVasive Modulus TLIF Interbody System (K172341), NuVasive Foundation-LL System (K152943) and NuVasive CoRoent Lumbar Interbody Implants System (K161230). 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. Based on review of publicly available materials at the time of this release. Simplify Medical is located in Sunnyvale, California. The company offers implants, fixation products, intraoperative monitoring (IOM) services, disposables, and biologics for use in spinal surgery. As an innovator in the TLIF space, NuVasive technology helps deliver an optimized surgical experience from single-level degenerative to multi-level deformity cases. NuVasive is developing the operating room of the future. Please close the page and access the Company Store via Okta. 2.0 Scope 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. Height 25cm, diameter 7cm - Volume: 500 ml. 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 . WestCMR does not represent or claim any relationship to the respective companies or their equipment or products, names are used for reference only. Investor Conference Call Propel DBM is donated human bone that has been demineralized to remove the minerals and cells contained in the bone while retaining the collagen matrix and growth factors, including bone morphogenetic proteins, inherent to the tissue. Excluding VAT and shipping. Today, the FDA is providing updated information and recommendations on the titanium-based Precice devices. Robert Eastlack and Gregory Mundis. NuVasive Launches Modulus ALIF. This can minimize the potential risks while also minimizing the risks associated with repetitive surgical interventions and suboptimal conversion to alternative therapies mid-treatment. 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. At NuVasive, we transform surgery, advanced care, and change lives. For the best experience on our site, be sure to turn on Javascript in your browser. RCCmyf(&3Tn@}M S,3c6qr|b2#JQ|%^@ZQTK,1gCTS pD"d(GR ~h'! At NuVasive, we transform surgery, advanced care, and change lives. Unhappy? Eastlack and Mundis as they discuss, Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion?, recently published in the Journal of Neurosurgery Spine. The NuVasive CPD program focuses on surgeon development through the design and delivery of innovative clinical education programs. Exclusive news, data and analytics for financial market professionals, Reporting by Greg Roumeliotis in New York, US FDA declines to approve Ascendis' hormone disorder therapy, Astellas Pharma buys Iveric Bio for $5.9 billion, Pfizer, BioNTech propose EU pays half for each cancelled COVID dose, Financial Times reports, Indian cough syrup: mystery middleman may be new clue, Enbridge acquires gas storage facility in British Columbia for $295 million, Adani-owned NDTV profit plunges about 98% on weak advertising demand, U.S. FAA opens new direct plane routes ahead of summer travel, Russia temporarily halts gas supply to Armenia for planned maintenance, Norwegian Cruise lifts profit forecast on higher ticket prices, steady demand. Number of products: 188 ACCESS SURGICAL MAXCESS KIT ACCESS SYSTEM MAXCESS ALIF TI INTERFIXATED - BOLTS ALIF TI INTERFIXATED - CAGE The purpose of this document is to define the standardization of cosmetic and visual acceptance criteria for NuVasive products upon receipt from the manufacturer. window.dataLayer = window.dataLayer || []; These two parts work in conjunction to allow the spine to bend, twist, and also provide shock absorption. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. 50 - 99 pieces - 8,75. 1997-2023 WestCMR. All Trademarks & Logos belong to their respective owners. Check out The Better Way Back, a free patient support program for those suffering from a spinal condition. Forward-looking statements include, but are not limited to, statements about the potential benefits of the acquisition, including the expected impact on future financial and operating results, and post-acquisition plans and intentions. STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG. We do not practice medicine or provide medical services or advice as a part of this website. The disc is comprised of two parts, a tough and fibrous outer layer (annulus fibrosis), and a soft, gelatinous center (nucleus pulposus). One position. The Company expects the acquisition to accelerate net sales growth and be accretive to non-GAAP diluted earnings per share in 2022. 8050015: NuVasive NVM5 EMG Needle ModuleExpired NuVasive NuVasive. Malone, H., Mundis, G. M., Jr., Collier, M, et al. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. $749.00. The site is secure. About NuVasive Surgical efficiency. Its shares are down 2% year-to-date, compared to a 10% rise in the shares of Globus Medical. All rights reserved. NuVasive is the fastest growing, full-line spine company. NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. Prices(minimum order quantity 10 pieces)10 - 24 pieces - 22,6525 - 49 pieces - 19,3050 - 100 pieces - 17,60more than 100 pieces - please contact us for a new quote.Expected delivery: 3 weeks. 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. To learn more, visit www.simplifymedical.com. 1. Indications For Use NUWAVE is a germicide intended to disinfect non-critical medical devices and equipment surfaces including CPAP masks, tubing and water chambers. Reuters provides business, financial, national and international news to professionals via desktop terminals, the world's media organizations, industry events and directly to consumers. Leading Independent Proxy Advisory Firm Glass Lewis Joins ISS in Recommending NuVasive Shareholders Vote "FOR" the Proposed Merger with Globus Medical, Leading Independent Proxy Advisory Firm ISS Recommends NuVasive Shareholders Vote "FOR" the Proposed Merger with Globus Medical, NuVasive to Participate in Upcoming Global Spine Conferences, NuVasive Specialized Orthopedics Expands Indications of Precice Limb Lengthening System to Treat Pediatric Patients.

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