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Data / Medical devices / Intervertebral Fusion Device With Integrated Fixation, Cervical

Intervertebral Fusion Device With Integrated Fixation, Cervical (OVE): 207 FDA-registered makers in 12 countries

207 establishments in 12 countries are registered with the FDA to make Intervertebral Fusion Device With Integrated Fixation, Cervical (product code OVE, Class 2, 21 CFR 888.3080). 78 of them have a 510(k) clearance or PMA approval on file and 5 have a recall event. The FDA has issued 169 510(k) clearances under this code, the latest on October 2, 2026, and lists 12 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
OVE
Device class
2
Regulation
888.3080
Medical specialty
Orthopedic
Implant
Yes

Makers by country

CountryMakers
United States146
France16
Germany12
Switzerland10
South Korea7
China5
Malaysia3
South Africa2
Belgium2
Netherlands2
Taiwan1
India1

Makers of Intervertebral Fusion Device With Integrated Fixation, Cervical

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Seaspine Orthopedics CorporationCarlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer10November 28, 2023000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer8August 6, 2019010api.fda.gov
Genesys SpineAustin, TX, United StatesManufacturer6February 7, 2025000api.fda.gov
4web Inc.Frisco, TX, United StatesSpecification developer5December 11, 2025000api.fda.gov
Choice Spine LLCKnoxville, TN, United StatesComplaint file establishment, Specification developer5September 14, 2023000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer5November 13, 2019000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesManufacturer, Specification developer5December 7, 2015000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer, Repackager or relabeler5August 6, 2019000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer5November 13, 2019000api.fda.gov
Silony Medical GMBHLeinfelden-Echterdingen Baden-Wurttemberg, GermanyComplaint file establishment, Specification developer5June 24, 2015000api.fda.gov
Spinal Elements, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer5August 1, 2016000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer5July 25, 2012000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer5July 25, 2012000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer4December 22, 2025000api.fda.gov
Life SpineHuntley, IL, United StatesSpecification developer4October 19, 2023000api.fda.gov
Medtronic Puerto Rico Operations Co., HumacaoHumacao, PR, United StatesManufacturer4January 21, 2015000api.fda.gov
Medtronic Sofamor Danek Deggendorf GMBHDEGGENDORF Bavaria, GermanyManufacturer4January 21, 2015000api.fda.gov
Nexus Spine, L.L.C.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer4June 22, 2026000api.fda.gov
Nexus Spine, LLC.Lehi, UT, United StatesComplaint file establishment, Specification developer4June 22, 2026000api.fda.gov
Titan Spine, a Division of MedtronicMilwaukee, WI, United StatesManufacturer4August 6, 2019000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesComplaint file establishment, Repackager or relabeler, Specification developer4June 28, 2017000api.fda.gov
ZavationFlowood, MS, United StatesComplaint file establishment, Manufacturer, Specification developer4August 12, 2022000api.fda.gov
CG MedTech Co., Ltd.Uijeongbu-si Gyeonggi, South KoreaManufacturer3April 19, 2024010api.fda.gov
Spineart SAPlan-les-Ouates, SwitzerlandComplaint file establishment, Specification developer3May 10, 2024000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer3January 21, 2015000api.fda.gov
Alphatec Spine, Inc.Carlsbad, CA, United StatesManufacturer, Specification developer2December 18, 2020000api.fda.gov
Alphatec Spine, Inc.Memphis, TN, United StatesManufacturer2December 18, 2020000api.fda.gov
Camber Spine TechnologiesKing of Prussia, PA, United StatesComplaint file establishment, Manufacturer, Specification developer2March 22, 2023000api.fda.gov
Clariance-SasBEAURAINS Hauts-de-France, FranceComplaint file establishment, Manufacturer, Specification developer2March 22, 2024000api.fda.gov
Evolution Spine, LLCDallas, TX, United StatesComplaint file establishment, Manufacturer, Specification developer2February 4, 2026000api.fda.gov
GS Medical Co., Ltd.Heungdeok-gu, Cheongju-si Chungbuk, South KoreaManufacturer2July 20, 2023000api.fda.gov
Kyocera Medical Technologies, Inc.Redlands, CA, United StatesComplaint file establishment, Specification developer2December 22, 2022000api.fda.gov
LDR MedicalSainte-Savine Aube, FranceSpecification developer2December 7, 2015000api.fda.gov
Medacta International SACastel San Pietro Ticino, SwitzerlandComplaint file establishment, Manufacturer2November 6, 2020000api.fda.gov
Medacta International SARancate Ticino, SwitzerlandComplaint file establishment, Manufacturer2November 6, 2020000api.fda.gov
Nexxt Spine LLCNoblesville, IN, United StatesComplaint file establishment, Manufacturer2March 23, 2020000api.fda.gov
Nuvasive, Inc.Guaynabo, PR, United StatesManufacturer2November 13, 2019000api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesComplaint file establishment, Manufacturer2June 17, 2016000api.fda.gov
Precision Spine, Inc.Pearl, MS, United StatesManufacturer2January 12, 2021000api.fda.gov
Safe Orthopaedics SASFleurieux-Sur-L'Arbresle Rhone, FranceManufacturer2January 10, 2022000api.fda.gov
Spine Wave, Inc.Shelton, CT, United StatesManufacturer, Specification developer2November 1, 2017000api.fda.gov
Spinevision SASAntony Hauts-de-Seine, FranceComplaint file establishment, Manufacturer2November 14, 2022000api.fda.gov
Zhejiang Decans Medical Devices Co.,ltd.Jiaxing Zhejiang, ChinaManufacturer2April 20, 2026000api.fda.gov
Acuity Surgical Devices, LLCIrving, TX, United StatesManufacturer1July 30, 2025000api.fda.gov
Additive ImplantsPhoenix, AZ, United StatesSpecification developer1July 16, 2021000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer1May 25, 2016000api.fda.gov
Atlas Spine Inc.Jupiter, FL, United StatesManufacturer1February 28, 2020000api.fda.gov
AVALIGN TECHNOLOGIES, Inc.Fort Wayne, IN, United StatesSpecification developer1June 18, 2026000api.fda.gov
Astura MedicalIrving, TX, United StatesComplaint file establishment, Specification developer1October 26, 2020000api.fda.gov
CTL Medical CorporationCarrollton, TX, United StatesComplaint file establishment, Manufacturer, Specification developer1October 11, 2018000api.fda.gov
Demetra, Inc.Germantown, TN, United StatesComplaint file establishment, Specification developer1November 18, 2022000api.fda.gov
Eagle Medical Packaging Sterilization, Inc.Paso Robles, CA, United StatesContract manufacturer, Repackager or relabeler1October 21, 2016000api.fda.gov
Elevation SpineMonterey, CA, United StatesSpecification developer1August 7, 2019000api.fda.gov
Eminent Spine, LLCPlano, TX, United StatesManufacturer1November 5, 2021000api.fda.gov
Holmed LLCAttleboro, MA, United StatesContract manufacturer, Manufacturer1April 13, 2010000api.fda.gov
INNO Holdings Inc.Millcreek, UT, United StatesManufacturer1September 25, 2025000api.fda.gov
Jeil Medical CorporationSiheung-si Gyeonggi, South KoreaManufacturer1June 27, 2025000api.fda.gov
Jeil Medical CorporationSeoul, South KoreaManufacturer1June 27, 2025000api.fda.gov
K2M, Inc.Leesburg, VA, United StatesManufacturer, Specification developer1August 24, 2011010api.fda.gov
Medicrea InternationalRILLIEUX-LA-PAPE Auvergne-Rhone-Alpes, FranceManufacturer1September 3, 2021000api.fda.gov
Medyssey Co., Ltd.Jecheon-si Chungbuk, South KoreaManufacturer1June 15, 2026000api.fda.gov
Mirus, LLCMarietta, GA, United StatesManufacturer1October 27, 2023000api.fda.gov
Medtronic (Changzhou) Medical Devices Technology Co., LtdChangzhou Jiangsu, ChinaManufacturer1January 21, 2015000api.fda.gov
NanoHive Medical LLCWoburn, MA, United StatesManufacturer, Specification developer1December 12, 2022000api.fda.gov
Osseus Fusion Systems LLCDallas, TX, United StatesSpecification developer1August 21, 2026000api.fda.gov
Omnia MedicalMorgantown, WV, United StatesSpecification developer1November 15, 2022000api.fda.gov
Organ Eco TechSeongnam-Si Gyeonggi, South KoreaManufacturer1November 13, 2019000api.fda.gov
Pro Surgical, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer1November 20, 2024000api.fda.gov
Rhausler, Inc.Fremont, CA, United StatesSpecification developer1November 29, 2011000api.fda.gov
RSB Spine LLC.Wooster, OH, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1May 29, 2008000api.fda.gov
Signus Medizintechnik GMBHALZENAU Bavaria, GermanyComplaint file establishment, Exporter to the US, Manufacturer, Specification developer1February 11, 2025000api.fda.gov
Southern Medical (pty) LtdIRENE Gauteng, South AfricaComplaint file establishment, Exporter to the US, Manufacturer1August 14, 2023000api.fda.gov
SPINEFRONTIER, INC. DBA LESspine InnovationsBurlington, MA, United StatesManufacturer1May 8, 2018010api.fda.gov
Spineup IncMiami, FL, United StatesComplaint file establishment, Manufacturer, Specification developer1January 10, 2022000api.fda.gov
Stryker SpineAllendale, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer1April 22, 2011010api.fda.gov
SpineSmith Holdings, LLCAustin, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1December 5, 2012000api.fda.gov
Xenco Medical LLCSan Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1October 21, 2016000api.fda.gov
Zsfab IncWaltham, MA, United StatesComplaint file establishment, Specification developer1July 31, 2026000api.fda.gov
3D Medical SASMarolles en Brie Val-de-Marne, FranceContract manufacturer0000api.fda.gov
3D Systems - LayerwiseHeverlee Vlaams Brabant, BelgiumContract manufacturer0000api.fda.gov
A.F.T. MicromecaniqueFillinges Haute-Savoie, FranceContract manufacturer0000api.fda.gov
Alden Tool Company, Inc.Berlin, CT, United StatesContract manufacturer0000api.fda.gov
Alpes CN SASReignier-Esery Haute-Savoie, FranceContract manufacturer0000api.fda.gov
American Manufacturing And EngineeringMontgomeryville, PA, United StatesContract manufacturer0000api.fda.gov
Amnovis BVAarschot Flanders, BelgiumContract manufacturer0000api.fda.gov
AnthogyrSALLANCHES Haute-Savoie, FranceContract manufacturer0000api.fda.gov
Aps Materials, Inc.Dayton, OH, 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
Apex (Guangzhou) Tools & Orthopedics CompanyGuangzhou Guangdong, ChinaContract manufacturer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Avalign Additive / Slice Manufacturing StudiosAkron, OH, 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
Baat Medical Products B.V.Hengelo Overijssel, NetherlandsSpecification developer0000api.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&W Swiss, Inc.Clayton, OH, United StatesContract manufacturer0000api.fda.gov
Carlsmed, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer0000api.fda.gov
CefimecaLa Talaudiere Loire, FranceContract manufacturer0000api.fda.gov
Charles Pery & CieSCIONZIER Haute-Savoie, FranceContract manufacturer0000api.fda.gov
Christian Diener GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Classic Wire Cut Company, Inc.Valencia, CA, United StatesContract manufacturer, Manufacturer for export0000api.fda.gov
Coulot DecolletageCHATELLERAULT Vienne, FranceContract manufacturer0000api.fda.gov
CTL BiotecDaegu, South KoreaContract manufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Curiteva, Inc.Tanner, AL, United StatesContract manufacturer0000api.fda.gov
Complexus MedicalMishawaka, IN, United StatesContract manufacturer0000api.fda.gov
Donatelle Plastics, LLCNew Brighton, MN, United StatesContract manufacturer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.fda.gov
Elite Surgical Supplies (pty) LtdPretoria Gauteng, South AfricaManufacturer0000api.fda.gov
Eptam Plastics, LtdNorthfield, NH, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCFlorence, AL, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCCordova, TN, United StatesContract manufacturer0000api.fda.gov
Engineered Medical Systems, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Eurofins STERIPAC GMBHCalw-Altburg Baden-Wurttemberg, GermanyContract 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
Fmi Medisch BVSchiedam Zuid-Holland, NetherlandsContract manufacturer0000api.fda.gov
Friedrich Daniels GMBHSOLINGEN North Rhine-Westphalia, GermanyContract manufacturer0000api.fda.gov
Frueh Verpackungstechnik AGFehraltorf Zurich, SwitzerlandContract manufacturer0000api.fda.gov
Ferry Machine CorporationLittle Ferry, NJ, United StatesContract manufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
HC Biologics LLCMiami, FL, United StatesManufacturer0000api.fda.gov
Hoosier, Inc.Corona, CA, United StatesContract manufacturer0000api.fda.gov
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Intai Technology Corp. Implants Business UnitTaichung City, TaiwanContract manufacturer0000api.fda.gov
Isotis Orthobiologics, IncIrvine, CA, United StatesContract manufacturer0000api.fda.gov
J&B Precision, Inc.Cordova, TN, 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. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Balsthal)Balsthal Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Hagendorf)Hagendorf Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Mezzovico)Mezzovico Ticino, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Tuttlingen Manufacturing GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
LISI MEDICAL RemmeleCoon Rapids, MN, United StatesContract manufacturer0000api.fda.gov
Lowell,inc.Brooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Mainstream Medical DevicesAustin, TX, United StatesContract manufacturer0000api.fda.gov
Medical Modeling - A 3D Systems CompanyLittleton, CO, United StatesContract manufacturer0000api.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
Mount MFGMarquette, MI, 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
Ngage Medical ManufacturingHernando, MS, United StatesContract manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
NML Medical, LLCWest Carrollton, OH, United StatesContract manufacturer0000api.fda.gov
NextPhase Medical Devices LLCRochester, NH, United StatesContract manufacturer0000api.fda.gov
Oaktree AdditiveTampa, FL, United StatesContract manufacturer0000api.fda.gov
Oberg Medical Products CompanySarver, PA, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedics Switzerland GMBHBaden-Daettwil Aargau, SwitzerlandContract 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
Paragon Medical, Inc.Pierceton, IN, United StatesContract manufacturer0000api.fda.gov
Perryman CompanyHouston, PA, United StatesContract manufacturer0000api.fda.gov
Precera Medical Neyron SASMIRIBEL CEDEX Auvergne-Rhone-Alpes, FranceContract manufacturer0000api.fda.gov
Precision Edge Surgical Products CompanySault Sainte Marie, MI, United StatesContract manufacturer0000api.fda.gov
Precision Medical TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Procon Medizintechnik GMBHAlzenau Bavaria, GermanyContract manufacturer0000api.fda.gov
Ptumedical GMBHSpaichingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Pulse Technologies, Inc.Quakertown, PA, 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
ProCon Implants GmbHTuttlingen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, 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
Selenium Medical S.A.S.La Rochelle Charente-Maritime, FranceContract manufacturer0000api.fda.gov
SimagecROUSSET CEDEX Bouches-du-Rhone, FranceContract manufacturer0000api.fda.gov
Solco Biomedical Company India Private LimitedKADI Gujarat, IndiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdSimpang Ampat Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdPerai Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Straits Orthopaedics (MFG) Sdn BhdBandar Cassia Pulau Pinang, MalaysiaContract manufacturer0000api.fda.gov
Structure Medical, LLC.Naples, FL, United StatesContract manufacturer0000api.fda.gov
Stryker SpineCESTAS Nouvelle-Aquitaine, FranceContract manufacturer0000api.fda.gov
Surgical Instrument Manufacturers, LLCFenton, MO, United StatesContract manufacturer0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, 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
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
Watershed Idea Foundry, Inc.Carlsbad, CA, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Zhisu Health Tech Jiaxing Co. LtdTongxiang City Zhejiang, ChinaContract manufacturer0000api.fda.gov
Zibo Dante Co, LtdZibo City Shandong, ChinaContract manufacturer0000api.fda.gov
Zigg Design LLCNibley, UT, United StatesContract manufacturer0000api.fda.gov
rms SurgicalAnoka, MN, United StatesContract manufacturer0000api.fda.gov

Updated October 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.