nuvasive product catalog pdf
This can minimize the potential risks while also minimizing the risks associated with repetitive surgical interventions and suboptimal conversion to alternative therapies mid-treatment. Prices (minimum order quantity 125 pieces)125 - 249- 3,95250 - 500 - 2,90more than 500pieces - pleasecontact usfor a new quote. 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. NuVasives scale and global commercial channels will greatly accelerate the ability to bring the Simplify Disc to more surgeons and patients around the world.. 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. Expected delivery: 3 weeks. The materials on this website are for your general educational information only. 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). Before sharing sensitive information, make sure you're on a federal government site. 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 . Excluding VAT and shipping. If so, do not buy this item unless you are an authorized purchaser. 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. Surgical efficiency. Price: $5.00 per kit. 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 is translating nearly 20 years of leadership in spine care into innovative solutions for the pediatric market. For the best experience on our site, be sure to turn on Javascript in your browser. Simplify Medical is located in Sunnyvale, California. NuVasive offers solutions to alleviate patient symptoms. Together, we create a comprehensive, procedurally integrated cervical portfolio differentiated by technology and breadth. JPMorgan is serving as exclusive financial advisor to Simplify Medical, and Wilson Sonsini Goodrich& Rosati and Johnson Winter & Slatteryare serving as its legal counsel. Osteocel is human tissue donated specifically for human clinical use. This power bank is suitable for charging any device. devices: JNuVasiveo Lateral Plate System (K(061789), NuVasive Anterior Lumbar Plate (K072339) and Synthes Antegra-T System (K08 1568). The most comprehensive solution to manage all your complex and ever-expanding tax and compliance needs. 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 service located at Oisto.com is a website owned and operated by Oisto. Number of products: 188 ACCESS SURGICAL MAXCESS KIT ACCESS SYSTEM MAXCESS ALIF TI INTERFIXATED - BOLTS ALIF TI INTERFIXATED - CAGE For the best experience on our site, be sure to turn on Javascript in your browser. Published online June 3, 2022; DOI: 10.3171/2022.4.SPINE211070. The website is intended to provide information that might be of interest to users. Storz Hopkins 27015B 30 Degree Cystoscope Good Clean Image. The purpose of this document is to define the standardization of cosmetic and visual acceptance criteria for NuVasive products upon receipt from the manufacturer. 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. The Company will hold a conference call tomorrow, Feb. 25, 2021, at 4:30 p.m. NuVasive funded the upfront payment at closing using available cash on hand. NuVasive is developing the operating room of the future. The SRS-Schwab adult spinal deformity classification: 888 0 obj <>stream Transpsoas access 4. 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. As the innovation leader in spine, our goal is to provide you with comprehensive procedural solutions and enabling technology to change patient lives. 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. if( $robots ) : ?> 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 Our combined innovative technologies will create differentiated, comprehensive procedural solutions to better support surgeons, healthcare providers and patients. 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 . 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. A live webcast of the conference call will be available online from the Investor Relations page of the Companys website atwww.nuvasive.com. At Globus Medical, we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Excluding VAT and shipping. NuVasive declined to comment, while a Globus spokesperson did not immediately respond to a request for comment. 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). 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- Lehr MA, Oner CF, Delawi D, et al. 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. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made. About NuVasive NuVasive is the fastest growing, full-line spine company. Alignment Matters . N]1N6xB w4C !~)H-,E niwm"mm1PTkYn|,v]Pch%HjSOfSzuE*o ! Based in San Diego, NuVasive acquired Simplify Medical earlier this year with a $150 million upfront payment to expand its cervical spine technology portfolio. 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. NuVasive has developed the Reline 3D system to offer simultaneous and three-dimensional deformity correction through a simplified procedure. Prices (minimum order quantity 10 pieces)10 - 49 pieces - 66,7050 - 100 pieces - 63,10more than 100pieces - pleasecontact usfor a new quote. 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 This is why we show up every day, united and committed to our vision. These technologies include neuromonitoring, global alignment, rod bending, radiation reduction, imaging, and navigation. 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 FDA believes it is in the best interest of patients to make titanium-based Precice devices available in the United States. Telephone 1 858 9091800. There are no new recommendations regarding the stainless steel-based Precice devices since the July 2021 letter to health care providers. At NuVasive, we transform surgery, advanced care, and change lives. 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. The store will not work correctly in the case when cookies are disabled. Polini A, Pisignano D, Parodi M, et al. Efficacy of a standalone microporous ceramic vs. autograft in instrumented posterolateral spinal fusion; a multicenter, randomized, intra-patient controlled, non-inferiority trial. Address 7475 Lusk Blvd, San Diego, California, 92121. Open the catalog to page 2 What is causing my pain? Clarification that the device is intended for use only in patients 18 years and older, That patients should weigh 50 lbs. In a single expandable platform, Pulse integrates multiple enabling technologies to improve workflow, reduce variability, and increase the reproducibility of surgical outcomes. Learn how intelligent surgery can change your practice. As of date of publication, March 2017; data on file. 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. Prices excluding VAT and shipping. The disc is comprised of two parts, a tough and fibrous outer layer (annulus fibrosis), and a soft, gelatinous center (nucleus pulposus). Prices(minimum order quantity 25 pieces)25 - 49 pieces - 13,8750 - 99 pieces - 8,75100 - 200 pieces - 7,86more than 200 pieces - please contact us for a new quote. At NuVasive, we transform surgery, advanced care, and change lives. Information you read on this website cannot replace the relationship that you have with your healthcare professional. Read the press release NuVasive and Globus Medical are combining to bring together two well-regarded technology companies in the musculoskeletal industry. Photos are for illustration purposes only and may not depict the exact item. %PDF-1.5 % 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. Learn how the use of Attrax Putty in Modulus XLIF cages resulted in a 97.8% rate of bone bridging5 from Drs. Spine 2020;45(14):944-51. 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. NuVasive is headquartered in San Diego, California, the US. $650.00. Prices (minimum order quantity 50 pieces)50 - 99 pieces - 8.40100- 250 pieces - 7.50more than 250pieces - pleasecontact usfor a new quote. NuVasive also announced a voluntary recall to notify users of the updated labeling for titanium-based Precice devices listed here. ET / 1:30 p.m. PT to discuss these results. 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. Contraindications Discontinue use of NUWAVE if the user develops skin irritation such as acne or a rash around the mask contact area. An official website of the United States government, : STRYKER 502-427-030 VIDEO ARTHROSCOPE, 4MM 30 DEG. 'VUJ)(h. 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. NuVasive Launches Modulus ALIF. westcmrglobal.com |geosurgical.com |wareconsultingllc.com, West Coast Medical Resources | Serving the surgical community since 1997. (This story corrected name of Globus Medical in the headline from Global Medical). The Reline portfolio represents the evolution of posterior fixation technology, providing integrated Open and MAS procedural solutions. Build the strongest argument relying on authoritative content, attorney-editor expertise, and industry defining technology. $749.00. 3. BOX8-1Five Key Steps for Performing the XLIF Procedure 1. gtag('js', new Date()); NuVasive provides patient support and surgeon education. WestCMR does not provide advice, training, or clinical support. Screen for heightened risk individual and entities globally to help uncover hidden risks in business relationships and human networks. All quotes delayed a minimum of 15 minutes. 2.0 Scope To learn more, visit www.simplifymedical.com. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. The NuVasive Biologics portfolio includes procedurally integrated allogeneic bone graft substitutes and extenders, and synthetic ceramic bone graft substitutes intended to promote bone fusion. z0XF BEF1[ En>0XKO&`yNq-L 8)(T=f One position. NuVasive is developing the operating room of the future. Returns are simple. hbbd``b`I3@R $eL :X] BDLv ^e a$@@ He`bd^d100H xl Follow the actions provided by NuVasive in their, Report any adverse events or suspected events through. Advisors In this list are all medical devices registered by the ministry of health that are produced by the manufacturer NUVASIVE, INC. Name: NUVASIVE, INC. Ensure patients with a Precice device continue to receive appropriate follow-up monitoring. See here for a complete list of exchanges and delays. 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. NUVASIVE USA: 'NNUVASIVE' NuVasive, Inc. ~L ~ o 7475 Lusk Blvd. 2. 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. Three New Biologic Products for Spine Surgery. Prices (minimum order quantity 10 pieces)10 - 25- 64,9026- 50 - 61,60more than 50pieces - pleasecontact usfor a new quote. multi-level pathologies. CODE: NS10000565. Precice devices include adjustable rods placed inside a patient, which are driven by an internal magnetic mechanism. NuVasive BASE Interfixated Titanium System cleared in 510(k) K170592. -M=wPp4-x1rju]USL,}QBKH`X =!MeB&Tb| We do not practice medicine or provide medical services or advice as a part of this website. All Trademarks & Logos belong to their respective owners. Can a bioactive interbody device reduce the cost burden of achieving lateral lumbar fusion? Reimagine cervical spine surgery. Robert Eastlack and Gregory Mundis. The FDA encourages health care providers to report any adverse events or suspected adverse events experienced with NuVasive Precice devices. Information you read on this website cannot replace the relationship that you have with your healthcare professional.
