Data / Medical devices / Intervertebral Fusion Device With Integrated Fixation, Cervical / United States
FDA-registered makers of Intervertebral Fusion Device With Integrated Fixation, Cervical in the United States: 146 establishments
146 establishments in the United States are registered with the FDA to make Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE). 55 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- Intervertebral Fusion Device With Integrated Fixation, Cervical
- Product code
- OVE
- Country
- United States
Makers of Intervertebral Fusion Device With Integrated Fixation, Cervical in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Seaspine Orthopedics Corporation | Carlsbad, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 10 | November 28, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Specification developer | 8 | August 6, 2019 | 0 | 1 | 0 | api.fda.gov |
| Genesys Spine | Austin, TX, United States | Manufacturer | 6 | February 7, 2025 | 0 | 0 | 0 | api.fda.gov |
| 4web Inc. | Frisco, TX, United States | Specification developer | 5 | December 11, 2025 | 0 | 0 | 0 | api.fda.gov |
| Choice Spine LLC | Knoxville, TN, United States | Complaint file establishment, Specification developer | 5 | September 14, 2023 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Memphis, TN, United States | Manufacturer | 5 | November 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| Highridge Medical, LLC | Westminster, CO, United States | Manufacturer, Specification developer | 5 | December 7, 2015 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Sofamor Danek Usa, Inc. | Memphis, TN, United States | Manufacturer, Repackager or relabeler | 5 | August 6, 2019 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 5 | November 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| Spinal Elements, Inc. | Carlsbad, CA, United States | Complaint file establishment, Manufacturer | 5 | August 1, 2016 | 0 | 0 | 0 | api.fda.gov |
| Globus Medical, Inc. | Audubon, PA, United States | Manufacturer | 4 | December 22, 2025 | 0 | 0 | 0 | api.fda.gov |
| Life Spine | Huntley, IL, United States | Specification developer | 4 | October 19, 2023 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Puerto Rico Operations Co., Humacao | Humacao, PR, United States | Manufacturer | 4 | January 21, 2015 | 0 | 0 | 0 | api.fda.gov |
| Nexus Spine, L.L.C. | Salt Lake City, UT, United States | Complaint file establishment, Specification developer | 4 | June 22, 2026 | 0 | 0 | 0 | api.fda.gov |
| Nexus Spine, LLC. | Lehi, UT, United States | Complaint file establishment, Specification developer | 4 | June 22, 2026 | 0 | 0 | 0 | api.fda.gov |
| Titan Spine, a Division of Medtronic | Milwaukee, WI, United States | Manufacturer | 4 | August 6, 2019 | 0 | 0 | 0 | api.fda.gov |
| Xtant Medical Holdings, Inc. | Belgrade, MT, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 4 | June 28, 2017 | 0 | 0 | 0 | api.fda.gov |
| Zavation | Flowood, MS, United States | Complaint file establishment, Manufacturer, Specification developer | 4 | August 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Warsaw Orthopedic, Inc. | Warsaw, IN, United States | Manufacturer | 3 | January 21, 2015 | 0 | 0 | 0 | api.fda.gov |
| Alphatec Spine, Inc. | Carlsbad, CA, United States | Manufacturer, Specification developer | 2 | December 18, 2020 | 0 | 0 | 0 | api.fda.gov |
| Alphatec Spine, Inc. | Memphis, TN, United States | Manufacturer | 2 | December 18, 2020 | 0 | 0 | 0 | api.fda.gov |
| Camber Spine Technologies | King of Prussia, PA, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | March 22, 2023 | 0 | 0 | 0 | api.fda.gov |
| Evolution Spine, LLC | Dallas, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 2 | February 4, 2026 | 0 | 0 | 0 | api.fda.gov |
| Kyocera Medical Technologies, Inc. | Redlands, CA, United States | Complaint file establishment, Specification developer | 2 | December 22, 2022 | 0 | 0 | 0 | api.fda.gov |
| Nexxt Spine LLC | Noblesville, IN, United States | Complaint file establishment, Manufacturer | 2 | March 23, 2020 | 0 | 0 | 0 | api.fda.gov |
| Nuvasive, Inc. | Guaynabo, PR, United States | Manufacturer | 2 | November 13, 2019 | 0 | 0 | 0 | api.fda.gov |
| Orthofix Us LLC | Lewisville, TX, United States | Complaint file establishment, Manufacturer | 2 | June 17, 2016 | 0 | 0 | 0 | api.fda.gov |
| Precision Spine, Inc. | Pearl, MS, United States | Manufacturer | 2 | January 12, 2021 | 0 | 0 | 0 | api.fda.gov |
| Spine Wave, Inc. | Shelton, CT, United States | Manufacturer, Specification developer | 2 | November 1, 2017 | 0 | 0 | 0 | api.fda.gov |
| Acuity Surgical Devices, LLC | Irving, TX, United States | Manufacturer | 1 | July 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Additive Implants | Phoenix, AZ, United States | Specification developer | 1 | July 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| Atlas Spine Inc. | Jupiter, FL, United States | Manufacturer | 1 | February 28, 2020 | 0 | 0 | 0 | api.fda.gov |
| AVALIGN TECHNOLOGIES, Inc. | Fort Wayne, IN, United States | Specification developer | 1 | June 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Astura Medical | Irving, TX, United States | Complaint file establishment, Specification developer | 1 | October 26, 2020 | 0 | 0 | 0 | api.fda.gov |
| CTL Medical Corporation | Carrollton, TX, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | October 11, 2018 | 0 | 0 | 0 | api.fda.gov |
| Demetra, Inc. | Germantown, TN, United States | Complaint file establishment, Specification developer | 1 | November 18, 2022 | 0 | 0 | 0 | api.fda.gov |
| Eagle Medical Packaging Sterilization, Inc. | Paso Robles, CA, United States | Contract manufacturer, Repackager or relabeler | 1 | October 21, 2016 | 0 | 0 | 0 | api.fda.gov |
| Elevation Spine | Monterey, CA, United States | Specification developer | 1 | August 7, 2019 | 0 | 0 | 0 | api.fda.gov |
| Eminent Spine, LLC | Plano, TX, United States | Manufacturer | 1 | November 5, 2021 | 0 | 0 | 0 | api.fda.gov |
| Holmed LLC | Attleboro, MA, United States | Contract manufacturer, Manufacturer | 1 | April 13, 2010 | 0 | 0 | 0 | api.fda.gov |
| INNO Holdings Inc. | Millcreek, UT, United States | Manufacturer | 1 | September 25, 2025 | 0 | 0 | 0 | api.fda.gov |
| K2M, Inc. | Leesburg, VA, United States | Manufacturer, Specification developer | 1 | August 24, 2011 | 0 | 1 | 0 | api.fda.gov |
| Mirus, LLC | Marietta, GA, United States | Manufacturer | 1 | October 27, 2023 | 0 | 0 | 0 | api.fda.gov |
| NanoHive Medical LLC | Woburn, MA, United States | Manufacturer, Specification developer | 1 | December 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Osseus Fusion Systems LLC | Dallas, TX, United States | Specification developer | 1 | August 21, 2026 | 0 | 0 | 0 | api.fda.gov |
| Omnia Medical | Morgantown, WV, United States | Specification developer | 1 | November 15, 2022 | 0 | 0 | 0 | api.fda.gov |
| Pro Surgical, Inc. | Carlsbad, CA, United States | Complaint file establishment, Manufacturer | 1 | November 20, 2024 | 0 | 0 | 0 | api.fda.gov |
| Rhausler, Inc. | Fremont, CA, United States | Specification developer | 1 | November 29, 2011 | 0 | 0 | 0 | api.fda.gov |
| RSB Spine LLC. | Wooster, OH, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | May 29, 2008 | 0 | 0 | 0 | api.fda.gov |
| SPINEFRONTIER, INC. DBA LESspine Innovations | Burlington, MA, United States | Manufacturer | 1 | May 8, 2018 | 0 | 1 | 0 | api.fda.gov |
| Spineup Inc | Miami, FL, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | January 10, 2022 | 0 | 0 | 0 | api.fda.gov |
| Stryker Spine | Allendale, NJ, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | April 22, 2011 | 0 | 1 | 0 | api.fda.gov |
| SpineSmith Holdings, LLC | Austin, TX, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | December 5, 2012 | 0 | 0 | 0 | api.fda.gov |
| Xenco Medical LLC | San Diego, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 1 | October 21, 2016 | 0 | 0 | 0 | api.fda.gov |
| Zsfab Inc | Waltham, MA, United States | Complaint file establishment, Specification developer | 1 | July 31, 2026 | 0 | 0 | 0 | api.fda.gov |
| Alden Tool Company, Inc. | Berlin, CT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| American Manufacturing And Engineering | Montgomeryville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aps Materials, Inc. | Dayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Elmhurst | Elmhurst, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Memphis | Lexington, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ARCH Medical Solutions - Olive Branch | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Kentwood, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Axial Medical | Ivyland, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Acero Precision | West Chester, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Autocam Medical | Murfreesboro, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Additive / Slice Manufacturing Studios | Akron, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Avalign Instruments & Implants | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| B & G MFG. Co. | Hatfield, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Banister Tool, Inc. | Pflugerville, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Branch Medical Group | Eagleville, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Branch Medical Group | Limerick, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Bradshaw Medical Inc. | Kenosha, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C&W Swiss, Inc. | Clayton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carlsmed, Inc. | Carlsbad, CA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Classic Wire Cut Company, Inc. | Valencia, CA, United States | Contract manufacturer, Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Culver Tool & Engineering | Plymouth, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Curiteva, Inc. | Tanner, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Complexus Medical | Mishawaka, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Donatelle Plastics, LLC | New Brighton, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Donson Machine Company | Alsip, IL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Eptam Plastics, Ltd | Northfield, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medical, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medical, LLC | Florence, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Elite Medical, LLC | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Engineered Medical Systems, LLC | Bartlett, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Oakland, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| First Article Inc | Souderton, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flex-Cell Precision, Inc. | Lancaster, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ferry Machine Corporation | Little Ferry, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Harwood Design, Inc. | Bristol, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HC Biologics LLC | Miami, FL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hoosier, Inc. | Corona, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Instru-Med Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Isotis Orthobiologics, Inc | Irvine, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| J&B Precision, Inc. | Cordova, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jatex, Inc. | Nappanee, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Brandywine) | W Chester, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jabil Inc. (Monument) | Monument, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LH Medical Corporation | Fort Wayne, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| LISI MEDICAL Remmele | Coon Rapids, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lowell,inc. | Brooklyn Park, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mainstream Medical Devices | Austin, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medical Modeling - A 3D Systems Company | Littleton, CO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micro Precision Swiss | Santa Ana, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Micropulse Inc | Columbia City, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC. | Fall River, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mount MFG | Marquette, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mendell | Lakeville, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Metal Craft Machine & Engineering, Inc. | Elk River, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Microcision LLC | Pennsauken, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Millstone Medical Outsourcing LLC | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ngage Medical Manufacturing | Hernando, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NGInstruments, Inc dba Avalign Cutting Instruments | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NML Medical, LLC | West Carrollton, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| NextPhase Medical Devices LLC | Rochester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oaktree Additive | Tampa, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oberg Medical Products Company | Sarver, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Osteomni Inc | Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Olive Branch Distribution Center | Olive Branch, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Orchid Orthopedic Solutions Alabama LLC | Arab, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical, Inc. | Pierceton, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Perryman Company | Houston, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Edge Surgical Products Company | Sault Sainte Marie, MI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Medical Technologies | Warsaw, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pulse Technologies, Inc. | Quakertown, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Paragon Medical Inc. | Smithfield, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Phillips Precision Inc | Elmwood Park, NJ, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Precision Medical Technologies- North Manchester Manufacturing Facility | N Manchester, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Quality Tech Services, LLC | Bloomington, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Riverside Machine & Engineering, Inc. | Eau Claire, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| RMS Co. | Minneapolis, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Naples, FL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Surgical Instrument Manufacturers, LLC | Fenton, MO, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Structure Medical, LLC. | Mooresville, NC, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turnco Tool & Instrument, Inc. | Georgetown, TX, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Turner Medical Inc. | Athens, AL, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tangible Solutions, Inc. DBA Marle Tangible, Inc. | Fairborn, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Tegra Medical | Hernando, MS, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| The E F PRECISION GROUP | Willow Grove, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Victoria Precision Inc. | Trevose, PA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vorzeigen | Connersville, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vy Spine, LLC | Bountiful, UT, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Watershed Idea Foundry, Inc. | Carlsbad, CA, United States | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zigg Design LLC | Nibley, UT, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| rms Surgical | Anoka, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.