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Data / Medical devices / Spinal Vertebral Body Replacement Device / United States

FDA-registered makers of Spinal Vertebral Body Replacement Device in the United States: 144 establishments

144 establishments in the United States are registered with the FDA to make Spinal Vertebral Body Replacement Device (product code MQP). 40 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.

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Device
Spinal Vertebral Body Replacement Device
Product code
MQP
Country
United States

Makers of Spinal Vertebral Body Replacement Device in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer32April 4, 2019000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer, Repackager or relabeler20January 16, 2019000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesManufacturer, Specification developer16May 16, 2017000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer14February 26, 2020000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer13May 1, 2008000api.fda.gov
Medtronic Puerto Rico Operations Co., HumacaoHumacao, PR, United StatesManufacturer13April 4, 2019000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer, Repackager or relabeler13April 4, 2019000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer11May 8, 2019000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer11February 26, 2020010api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer11May 23, 2019010api.fda.gov
K2M, Inc.Leesburg, VA, United StatesComplaint file establishment, Manufacturer, Specification developer8November 28, 2018000api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesComplaint file establishment, Manufacturer, Specification developer6February 24, 2006010api.fda.gov
Spine Wave, Inc.Shelton, CT, United StatesManufacturer, Specification developer6February 19, 2015000api.fda.gov
Seaspine Orthopedics CorporationCarlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer5October 23, 2007000api.fda.gov
Alphatec Spine, Inc.Carlsbad, CA, United StatesManufacturer, Specification developer4October 6, 2023010api.fda.gov
Alphatec Spine, Inc.Memphis, TN, United StatesManufacturer4October 6, 2023000api.fda.gov
Stryker SpineAllendale, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer4August 3, 2006000api.fda.gov
Choice Spine LLCKnoxville, TN, United StatesComplaint file establishment, Specification developer3February 22, 2019000api.fda.gov
Spinal Elements, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer3December 22, 2015000api.fda.gov
Camber Spine TechnologiesKing of Prussia, PA, United StatesComplaint file establishment, Repackager or relabeler, Specification developer2February 2, 2018000api.fda.gov
INNO Holdings Inc.Millcreek, UT, United StatesManufacturer2December 22, 2006000api.fda.gov
Nuvasive, Inc.Guaynabo, PR, United StatesManufacturer2February 26, 2020000api.fda.gov
Omnia MedicalMorgantown, WV, United StatesSpecification developer2October 26, 2017000api.fda.gov
RSB Spine LLC.Wooster, OH, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer2June 11, 2007000api.fda.gov
Zimmer Trabecular Metal Technology, Inc.Parsippany, NJ, United StatesContract manufacturer, Manufacturer2May 30, 2007000api.fda.gov
Atlas Spine Inc.Jupiter, FL, United StatesManufacturer1February 26, 2007010api.fda.gov
Astura MedicalIrving, TX, United StatesComplaint file establishment, Specification developer1March 8, 2024000api.fda.gov
Blustone Synergy, LLCPueblo, CO, United StatesSpecification developer1December 21, 2017000api.fda.gov
CTL Medical CorporationCarrollton, TX, United StatesComplaint file establishment, Manufacturer, Specification developer1January 9, 2008000api.fda.gov
Deroyal Industries, Inc.Powell, TN, United StatesComplaint file establishment, Specification developer1April 5, 2012000api.fda.gov
Foundation Surgical GroupScottsdale, AZ, United StatesComplaint file establishment, Specification developer1November 7, 2024000api.fda.gov
Holmed LLCAttleboro, MA, United StatesContract manufacturer, Manufacturer1December 21, 2005000api.fda.gov
Ortho Development Corp.Draper, UT, United StatesComplaint file establishment, Manufacturer1January 25, 2007000api.fda.gov
SpineSmith Holdings, LLCAustin, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1July 2, 2008000api.fda.gov
Titan Spine, a Division of MedtronicMilwaukee, WI, United StatesManufacturer1December 8, 2003000api.fda.gov
Ulrich Medical Usa, Inc.Plano, TX, United StatesSpecification developer1November 16, 2018000api.fda.gov
UOC USA Inc.Irvine, CA, United StatesManufacturer, Manufacturer for export1October 24, 2001000api.fda.gov
Unified Spine, LLCWesterville, OH, United StatesManufacturer, Specification developer1August 24, 2007000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1December 24, 2013000api.fda.gov
ZavationFlowood, MS, United StatesComplaint file establishment, Manufacturer, Specification developer1December 23, 2020000api.fda.gov
American Manufacturing And EngineeringMontgomeryville, PA, United StatesContract manufacturer0000api.fda.gov
Aps Materials, Inc.Dayton, OH, United StatesContract manufacturer0000api.fda.gov
ARCH - QuakertownQuakertown, PA, United StatesContract manufacturer0000api.fda.gov
Arch Medical Solutions - Philadelphia, LLC Dba Jade Precision Medical ComponentsHuntingdon Valley, PA, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - ElmhurstElmhurst, IL, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisBartlett, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - MemphisLexington, TN, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - Olive BranchOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
Acero PrecisionWest Chester, PA, United StatesContract manufacturer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Avalign Delivery Systems DivisionGreenwood, IN, United StatesContract manufacturer0000api.fda.gov
Avalign Instruments & ImplantsFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
B & G MFG. Co.Hatfield, PA, United StatesContract manufacturer0000api.fda.gov
Banister Tool, Inc.Pflugerville, TX, United StatesContract manufacturer0000api.fda.gov
Branch Medical GroupEagleville, PA, United StatesContract manufacturer0000api.fda.gov
Branch Medical GroupLimerick, PA, United StatesContract manufacturer0000api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer0000api.fda.gov
C&A Tool Engineering, Inc. Auburn PlantAuburn, IN, United StatesContract manufacturer0000api.fda.gov
C&W Swiss, Inc.Clayton, OH, United StatesContract manufacturer0000api.fda.gov
C+a Tool Engineering, Inc.Churubusco, IN, United StatesContract manufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Complexus MedicalMishawaka, IN, United StatesContract manufacturer0000api.fda.gov
Design Standards Corp.Charlestown, NH, United StatesContract manufacturer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.fda.gov
Eminent Spine, LLCPlano, TX, United StatesManufacturer0000api.fda.gov
Eptam Plastics, LtdNorthfield, NH, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCCordova, TN, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationOakland, NJ, United StatesContract manufacturer0000api.fda.gov
First Article IncSouderton, PA, United StatesContract manufacturer0000api.fda.gov
Flex-Cell Precision, Inc.Lancaster, PA, United StatesContract manufacturer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Gauthier Biomedical, Inc.Grafton, WI, United StatesContract manufacturer0000api.fda.gov
Genesys SpineAustin, TX, United StatesManufacturer0000api.fda.gov
Hammill MFG. Co.Maumee, OH, United StatesContract manufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Hoosier, Inc.Corona, CA, United StatesContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Isotis Orthobiologics, IncIrvine, CA, United StatesContract manufacturer0000api.fda.gov
J&B Precision, Inc.Cordova, TN, United StatesContract manufacturer0000api.fda.gov
Jarvis Surgical Inc.Westfield, MA, United StatesContract manufacturer0000api.fda.gov
Jatex, Inc.Nappanee, IN, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Brandywine)W Chester, PA, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Elmira)Horseheads, NY, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Life Science Outsourcing, Inc.Brea, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
LISI MEDICAL REmmeleBig Lake, MN, United StatesContract manufacturer0000api.fda.gov
Lowell,inc.Brooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Mackay Manufacturing, Inc.Spokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Medtech LLCMillington, TN, United StatesContract manufacturer0000api.fda.gov
Met One Technologies, LLCEl Paso, TX, United StatesManufacturer, Specification developer0000api.fda.gov
Micro Precision SwissSanta Ana, CA, United StatesContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, United StatesContract manufacturer0000api.fda.gov
MendellLakeville, MN, United StatesContract manufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Microcision LLCPennsauken, NJ, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Nexxt Spine LLCNoblesville, IN, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
Ngage Medical ManufacturingHernando, MS, United StatesContract manufacturer0000api.fda.gov
NML Medical, LLCWest Carrollton, OH, United StatesContract manufacturer0000api.fda.gov
Odyssey Medical Technologies, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Osteomni IncMiami, FL, United StatesSpecification developer0000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Packaging Compliance Medical, LLCKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Perryman CompanyHouston, PA, United StatesContract manufacturer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Precision Forms, Inc.Butler, NJ, United StatesContract manufacturer0000api.fda.gov
Precision Medical TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Pulse Technologies, Inc.Quakertown, PA, United StatesContract manufacturer0000api.fda.gov
Paragon Medical - DaytonDayton, OH, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Castleton, IN, United StatesContract manufacturer0000api.fda.gov
Paragon Medical Inc.Smithfield, UT, United StatesContract manufacturer0000api.fda.gov
Phillips Precision IncElmwood Park, NJ, United StatesContract manufacturer0000api.fda.gov
Precision Medical Technologies- North Manchester Manufacturing FacilityN Manchester, IN, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
R.K. ManufacturingDanbury, CT, United StatesContract manufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
SINTX Technologies Inc.Salt Lake City, UT, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Naples, FL, United StatesContract manufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing IncClaypool, IN, United StatesContract manufacturer0000api.fda.gov
Symmetry Medical Manufacturing Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
TOMZ CorporationBerlin, CT, United StatesContract manufacturer0000api.fda.gov
Turnco Tool & Instrument, Inc.Georgetown, TX, United StatesContract manufacturer0000api.fda.gov
Turner Medical Inc.Athens, AL, United StatesContract manufacturer0000api.fda.gov
Tangible Solutions, Inc. DBA Marle Tangible, Inc.Fairborn, OH, United StatesContract manufacturer0000api.fda.gov
Tech Industries. Inc.Cleveland, OH, United StatesContract manufacturer0000api.fda.gov
Tegra MedicalHernando, MS, United StatesContract manufacturer0000api.fda.gov
The E F PRECISION GROUPWillow Grove, PA, United StatesContract manufacturer0000api.fda.gov
Victoria Precision Inc.Trevose, PA, United StatesContract manufacturer0000api.fda.gov
VorzeigenConnersville, IN, United StatesContract manufacturer0000api.fda.gov
Vy Spine, LLCBountiful, UT, United StatesManufacturer, Specification developer0000api.fda.gov
Xcix Design, LLCRichmond, UT, United StatesContract manufacturer0000api.fda.gov
Zigg Design LLCNibley, UT, United StatesContract manufacturer0000api.fda.gov
rms SurgicalAnoka, MN, United StatesContract manufacturer0000api.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.