Quantity Stainless Steel Bottle 13,87 Keeps your drinks cold for 8 hours and hot for 5 As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to change patient lives. Becoming the number one partner in pediatrics. Prices (minimum order quantity 50 pieces)50 - 99 pieces - 8.40100- 250 pieces - 7.50more than 250pieces - pleasecontact usfor a new quote. At this time, the FDA is not aware of reports of adverse events related to biocompatibility issues with titanium-based Precice devices. 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. Product images are for display only. 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. gtag('js', new Date()); 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). N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! Reimagine cervical spine surgery. Implant insertion Clarification that the device is intended for use only in patients 18 years and older, That patients should weigh 50 lbs. PDF NUVASIVE' 1 Nu Vasive Sage Lateral Plate System '4 0 D. Device Description Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. Do not implant more than two devices in a patient at once. We do not practice medicine or provide medical services or advice as a part of this website. Check out The Better Way Back, a free patient support program for those suffering from a spinal condition. 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. 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. About Simplify Medical All Trademarks & Logos belong to their respective owners. DLA Piper is serving as NuVasives legal counsel. NuVasive offers solutions to alleviate patient symptoms. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. Simplify Cervical Artificial Disc provides NuVasive most clinically effective technology in the cervical total disc replacement (cTDR) procedure segment, Expands growth opportunities and further differentiates Companys comprehensive portfolio across ACDF, PCF, and cTDR procedures. Excluding VAT and shipping. Prices (minimum order quantity 10 pieces)10 - 25- 64,9026- 50 - 61,60more than 50pieces - pleasecontact usfor a new quote. PLoS ONE 2011;6(10):1-8. NuVasive provides patient support and surgeon education. NuVasive is developing the operating room of the future. 1 Terran J, Schwab F, Shaffrey CI, et al. 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. The materials on this website are for your general educational information only. On November 30, 2021, NuVasive issued a field safety notice to inform health care providers of updated labeling and the ship hold in the United States was lifted for titanium-based Precice devices. Potential Biocompatibility Concerns with NuVasive Specialized 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 . An official website of the United States government, : Expected delivery: 3 weeks. Sign in to add this product to your favorites! STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG. var base_url = "https://www.medicaldevices24.com/"; WestCMR does not represent or claim any relationship to the respective companies or their equipment or products, names are used for reference only. $1,299.99. This reflects the technologys favorable growth and margin profile, combined with NuVasives substantial commercial capability and C360 portfolio integration. JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel. The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. Contraindications Discontinue use of NUWAVE if the user develops skin irritation such as acne or a rash around the mask contact area. Provide health care providers and patients access to an adequate supply of titanium-based Precice devices. ET / 1:30 p.m. PT to discuss these results. %%EOF About NuVasive PDF NuVasive, Incorporated September 26, 2019 Mr. Mark Job Responsible Propel DBM Putty and Gel serve as a bone graft extender (extremities, spine, pelvis) and bone void filler of the extremities and pelvis. Conmed Linvatec E9010 CoolFlex E9000 High Speed Drill. 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. 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. or more while undergoing treatment, and. Learn how intelligent surgery can change your practice. JavaScript seems to be disabled in your browser. Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070. Learn more about the value of Biologics Information you need When fusion is recommended $5,499.99. Propel DBM is donated human bone that has been demineralized to remove the minerals and cells contained in the bone while retaining the collagen matrix and growth factors, including bone morphogenetic proteins, inherent to the tissue. Osteoinduction of human mesenchymal stem cells by bioactive composite scaffolds without supplemental osteogenic growth factors. Duan R, Barbieri D, Luo X, et al. All Trademarks referred to are the property of their respective owners. Three New Biologic Products for Spine Surgery. Malone, H., Mundis, G. M., Jr., Collier, M, et al. Hear from Doug Bireley, Vice President of Global Product Marketing, product leadership, and spine surgeons across the globe. All rights reserved. Excluding VAT and shipping. You should always talk to your healthcare professional for diagnosis and treatment. PDF NuVasive, Incorporated Ms. Daniela Mahan, Esq., RAC 7475 Lusk Blvd That no more than two devices should be implanted at a time. NuVasive has struggled with the impact that healthcare staffing shortages and weaker demand for elective surgery have had on its sales since the onset of the COVID-19 pandemic. Additional predicates include: NuVasive Modulus XLIF Interbody System (K163230/K192760), NuVasive Modulus TLIF Interbody System (K172341), NuVasive Foundation-LL System (K152943) and NuVasive CoRoent Lumbar Interbody Implants System (K161230). The FDA believes it is in the best interest of patients to make titanium-based Precice devices available in the United States. devices: JNuVasiveo Lateral Plate System (K(061789), NuVasive Anterior Lumbar Plate (K072339) and Synthes Antegra-T System (K08 1568). Expected delivery: 3 weeks. hb```b````e`ad@ A(GcG!O HW7o.[S.8{bZx{f(*m(!$ d9>k=ggx rM},(qS>gz}":IHH]1s1@lL j,l l@6kzGkFGkfTt4E# `(AokavH8XVh|Pi\P(d. 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. RCCmyf(&3Tn@}M S,3c6qr|b2#JQ|%^@ZQTK,1gCTS pD"d(GR ~h'! You have not been assigned a username and password. NuVasive Company Profile - Office Locations, Competitors, Revenue The Reline portfolio represents the evolution of posterior fixation technology, providing integrated Open and MAS procedural solutions. Information you read on this website cannot replace the relationship that you have with your healthcare professional. An integrated technology platform to enable better spine surgery. Philips L12-5 Linear Probe - 50mm Compact 256-Element Transducer ~ BRAND NEW ~. Transaction Details %PDF-1.5 % Height 25cm, diameter 7cm - Volume: 500 ml. At NuVasive, we aspire to change a patients life every minute. This is why we show up every day, united and committed to our vision. *Data on file. Osteocel is human tissue donated specifically for human clinical use. 1Simplify Cervical Artificial Disc P200022. function gtag(){dataLayer.push(arguments);} 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. 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. Reuters, the news and media division of Thomson Reuters, is the worlds largest multimedia news provider, reaching billions of people worldwide every day. Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. 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- (?]pzk/l^-og'/Y Li3{__>^q,Ud$edzySvKZPz16,OEU[AI\P Access unmatched financial data, news and content in a highly-customised workflow experience on desktop, web and mobile. This power bank is suitable for charging any device. The Companys less-invasive, procedurally integrated surgical solutions are designed to deliver reproducible and clinically proven outcomes. 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. 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. 4. Propel DBM Putty Plus and Gel Plus contain added cancellous chips and serve as a bone graft extender (extremities, posterolateral spine, pelvis) and bone void filler of the extremities and pelvis. obtained from Document Control, or a reference copy may be viewed on the NuVasive Network Server. NV Dynamic Stimulation Clip and Inline Activator, For Nvm5 Nerve Monitoring System. With more than $1 billion in net sales, NuVasive has approximately 2,700 employees and operates in more than 50 countries serving surgeons, hospitals, and patients. Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. List of devices made by the manufacturer NUVASIVE, INC. /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive,. Fusion is primarily performed to eliminate the pain often caused by abnormal motion of the vertebrae. Robert Eastlack and Gregory Mundis. if( $robots ) : ?> The company offers implants, fixation products, intraoperative monitoring (IOM) services, disposables, and biologics for use in spinal surgery. 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. The unique microarchitecture of Attrax drives the differentiation of mesenchymal stem cells (MSCs) into bone-forming osteoblasts without added growth factors.2 The optimized microarchitecture of Attrax is engineered using tightly controlled parameters for a defined micropore size distribution within 0.3 to 1.1 microns, demonstrated to initiate greater bone formation compared to traditional ceramics.3, Attrax Putty is one of only a few bone grafting devices on the market supported by a Level I randomized controlled trial as a bone graft substitute in posterolateral spinal fusions.4. The subject NuVasives scale and global commercial channels will greatly accelerate the ability to bring the Simplify Disc to more surgeons and patients around the world.. Product Code: NKB, KWP, MNI, MNH, KWQ C. Predicate Devices The subject Nu Vasive Polyaxial Spinal Screws are substantially equivalent to the PreceptTM (K1025 14), Armada (K092287), and SplzeRx PPS (K090981) Systems currently distributed commercially in the U.S. by NuVasive. NuVasive is the fastest growing, full-line spine company. -M=wPp4-x1rju]USL,}QBKH`X =!MeB&Tb| PDF NuVasive, Incorporated Jessica LeBlanc Senior Specialist, Regulatory We do not practice medicine or provide medical services or advice as a part of this website. Lehr MA, Oner CF, Delawi D, et al. ][/ /:/m#zq_MRWDEFC]trU{3E$4 Zu"M c]$J]GT|x(`3@e> ia=?:Hr;Cebhde~^65. For the best experience on our site, be sure to turn on Javascript in your browser. Products :: NuVasive 2010460 EMG Endotracheal Tube, ENT Kit 6 - Oisto The Company expects the acquisition to accelerate net sales growth and be accretive to non-GAAP diluted earnings per share in 2022. Our team is inspired by the needs of these patients, and the surgeons and health care providers who treat them. Expected delivery: 3 weeks. Polini A, Pisignano D, Parodi M, et al. Open the catalog to page 2 What is causing my pain? NuVasive, 8050015, NuVasive NVM5 EMG Needle Module - eSutures The sale of this item may be subject to regulation by the U.S. Food and Drug Administration and state and local regulatory agencies. Before sharing sensitive information, make sure you're on a federal government site. NuVasive Acquires Simplify Medical - NuVasive 5. Information you read on this website cannot replace the relationship that you have with your healthcare professional. As of date of publication, March 2017; data on file. NuVasive is headquartered in San Diego, California, the US. One comprehensive system. Appropriate patient positioning 2. For more information, please visit www.nuvasive.com. Reuters provides business, financial, national and international news to professionals via desktop terminals, the world's media organizations, industry events and directly to consumers. The device is currently being evaluated in a separate IDE study in the U.S. for 2-level indications, pending FDA approval. Advisors 1. 2. 2020 - multi-level pathologies. The forward-looking statements contained herein are based on the current expectations and assumptions of NuVasive and not on historical facts. Number of products: 188 ACCESS SURGICAL MAXCESS KIT ACCESS SYSTEM MAXCESS ALIF TI INTERFIXATED - BOLTS ALIF TI INTERFIXATED - CAGE 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 It will also discuss the Simplify Medical transaction at that time. NuVasive provides patient support and surgeon education. 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. 50 - 99 pieces - 8,75. 8050015: NuVasive NVM5 EMG Needle ModuleExpired NuVasive NuVasive. NuVasive has developed the Reline 3D system to offer simultaneous and three-dimensional deformity correction through a simplified procedure. Precice devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism. Previously, on April 5, 2021, NuVasive had posted a statement informing health care providers of ongoing biocompatibility testing with Precice devices and placed a global ship hold for all Precice devices. z0XF BEF1[ En>0XKO&`yNq-L 8)(T=f Browse an unrivalled portfolio of real-time and historical market data and insights from worldwide sources and experts. The SRS-Schwab adult spinal deformity classification: 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. 789 0 obj <> endobj Fusion is a surgical procedure in which one or more of the vertebrae of the spine are joined together (fused) so that motion no longer occurs between them. For the best experience on our site, be sure to turn on Javascript in your browser. The store will not work correctly in the case when cookies are disabled. The acquisition of Simplify Medical adds the most clinically effective cTDR technology and further distinguishes NuVasive's cervical portfolio in the market. 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. This service located at Oisto.com is a website owned and operated by Oisto. NuVasive introduces new Reline 3D posterior fixation system Biomater Sci 2018;6:136-45. List of devices made by the manufacturer NUVASIVE, INC. Thu, October 4th, 2018. Learn how the use of Attrax Putty in Modulus XLIF cages resulted in a 97.8% rate of bone bridging5 from Drs. NuVasive Inc Company Profile - GlobalData endif; ?> NuVasive is developing the operating room of the future. from FortisBC Holdings Inc for C$400 million ($294.68 million). 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.
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