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

Intervertebral Fusion Device With Integrated Fixation, Lumbar (OVD): 227 FDA-registered makers in 17 countries

227 establishments in 17 countries are registered with the FDA to make Intervertebral Fusion Device With Integrated Fixation, Lumbar (product code OVD, Class 2, 21 CFR 888.3080). 73 of them have a 510(k) clearance or PMA approval on file and 12 have a recall event. The FDA has issued 205 510(k) clearances under this code, the latest on September 11, 2026, and lists 20 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
OVD
Device class
2
Regulation
888.3080
Medical specialty
Orthopedic
Implant
Yes

Makers by country

CountryMakers
United States172
Switzerland12
France12
Germany12
China3
Malaysia3
Belgium2
Netherlands2
Costa Rica1
United Kingdom1
South Korea1
Australia1
South Africa1
Singapore1
Taiwan1
India1
Ireland1

Makers of Intervertebral Fusion Device With Integrated Fixation, Lumbar

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
Globus Medical, Inc.Memphis, TN, United StatesManufacturer18June 16, 2023000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer14June 16, 2023000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesManufacturer, Specification developer12April 28, 2020050api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer11April 29, 2026000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer10October 28, 2024020api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer, Repackager or relabeler9October 28, 2024000api.fda.gov
Kyocera Medical Technologies, Inc.Redlands, CA, United StatesComplaint file establishment, Specification developer8April 21, 2023000api.fda.gov
K2M, Inc.Leesburg, VA, United StatesComplaint file establishment, Manufacturer, Specification developer7October 3, 2019000api.fda.gov
Medacta International SACastel San Pietro Ticino, SwitzerlandComplaint file establishment, Manufacturer7May 5, 2026000api.fda.gov
Medacta International SARancate Ticino, SwitzerlandComplaint file establishment, Manufacturer7May 5, 2026000api.fda.gov
Nuvasive, Inc.Guaynabo, PR, United StatesManufacturer6June 16, 2023000api.fda.gov
Seaspine Orthopedics CorporationCarlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer6April 13, 2018000api.fda.gov
Stryker SpineAllendale, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer6August 10, 2020010api.fda.gov
Spinal Elements, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer5February 25, 2026000api.fda.gov
ZavationFlowood, MS, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer5June 14, 2023000api.fda.gov
Acuity Surgical Devices, LLCIrving, TX, United StatesManufacturer4April 22, 2025010api.fda.gov
Alphatec Spine, Inc.Carlsbad, CA, United StatesManufacturer, Specification developer4September 3, 2025010api.fda.gov
Alphatec Spine, Inc.Memphis, TN, United StatesManufacturer4September 3, 2025000api.fda.gov
Carlsmed, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer4March 17, 2025000api.fda.gov
Clariance-SasBEAURAINS Hauts-de-France, FranceComplaint file establishment, Manufacturer, Specification developer4April 1, 2021000api.fda.gov
INNO Holdings Inc.Millcreek, UT, United StatesManufacturer4September 11, 2026000api.fda.gov
LDR MedicalSainte-Savine Aube, FranceSpecification developer4September 28, 2016000api.fda.gov
Life SpineHuntley, IL, United StatesSpecification developer4April 17, 2020000api.fda.gov
Medtronic Sofamor Danek Deggendorf GMBHDEGGENDORF Bavaria, GermanyManufacturer4November 2, 2017000api.fda.gov
Nexus Spine, L.L.C.Salt Lake City, UT, United StatesComplaint file establishment, Specification developer4April 30, 2025000api.fda.gov
Nexus Spine, LLC.Lehi, UT, United StatesComplaint file establishment, Specification developer4April 30, 2025000api.fda.gov
Silony Medical GMBHLeinfelden-Echterdingen Baden-Wurttemberg, GermanyComplaint file establishment, Specification developer4June 8, 2015000api.fda.gov
Spineart SAPlan-les-Ouates, SwitzerlandComplaint file establishment, Specification developer4July 18, 2024010api.fda.gov
Titan Spine, a Division of MedtronicMilwaukee, WI, United StatesManufacturer4January 8, 2020000api.fda.gov
Astura MedicalIrving, TX, United StatesComplaint file establishment, Repackager or relabeler, Specification developer3January 19, 2023000api.fda.gov
Camber Spine TechnologiesKing of Prussia, PA, United StatesComplaint file establishment, Specification developer3March 30, 2023000api.fda.gov
Evolution Spine, LLCDallas, TX, United StatesComplaint file establishment, Manufacturer, Specification developer3May 15, 2024000api.fda.gov
Medtronic (Changzhou) Medical Devices Technology Co., LtdChangzhou Jiangsu, ChinaManufacturer3November 2, 2017000api.fda.gov
Precision Spine, Inc.Pearl, MS, United StatesManufacturer3April 1, 2022000api.fda.gov
Spineology Inc.Saint Paul, MN, United StatesManufacturer3August 23, 2019000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer3August 21, 2015000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer3August 21, 2015000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer3July 26, 2012000api.fda.gov
4web Inc.Frisco, TX, United StatesSpecification developer2April 22, 2024000api.fda.gov
Aesculap AGTUTTLINGEN, DONAU Baden-Wurttemberg, GermanyManufacturer2August 4, 2011000api.fda.gov
Degen MedicalFlorence, SC, United StatesComplaint file establishment, Specification developer2December 8, 2025000api.fda.gov
Medtronic Puerto Rico Operations Co., HumacaoHumacao, PR, United StatesManufacturer2October 4, 2011000api.fda.gov
Mirus, LLCMarietta, GA, United StatesManufacturer2September 11, 2023000api.fda.gov
Medtronic Medical Costa Rica S.R.L.Coyol Alajuela, Costa RicaManufacturer2October 4, 2011000api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesComplaint file establishment, Manufacturer, Specification developer2September 8, 2016010api.fda.gov
Pro Surgical, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2June 24, 2025000api.fda.gov
SpineSmith Holdings, LLCAustin, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer2October 11, 2012000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer2August 21, 2015000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesRepackager or relabeler, Specification developer2August 28, 2017010api.fda.gov
Altus PartnersWest Chester, PA, United StatesSpecification developer1April 19, 2022000api.fda.gov
Aurora Spine, Inc.Carlsbad, CA, United StatesManufacturer, Specification developer1May 27, 2022000api.fda.gov
AVALIGN TECHNOLOGIES, Inc.Fort Wayne, IN, United StatesSpecification developer1July 10, 2025000api.fda.gov
Axis Spine Technologies LtdLeeds, United KingdomComplaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Reprocessor, Specification developer1September 29, 2021000api.fda.gov
Biogennix, LLCIrvine, CA, United StatesManufacturer1February 19, 2015000api.fda.gov
Curiteva, Inc.Tanner, AL, United StatesContract manufacturer, Manufacturer1June 18, 2025000api.fda.gov
Choice Spine LLCKnoxville, TN, United StatesComplaint file establishment, Specification developer1May 16, 2018000api.fda.gov
Eminent Spine, LLCPlano, TX, United StatesManufacturer1October 17, 2022000api.fda.gov
Foundation Surgical GroupScottsdale, AZ, United StatesComplaint file establishment, Specification developer1October 2, 2024000api.fda.gov
GS Medical Co., Ltd.Heungdeok-gu, Cheongju-si Chungbuk, South KoreaManufacturer1December 3, 2010000api.fda.gov
Medicrea InternationalRILLIEUX-LA-PAPE Auvergne-Rhone-Alpes, FranceManufacturer1January 15, 2015010api.fda.gov
Nexxt Spine LLCNoblesville, IN, United StatesComplaint file establishment, Manufacturer1December 15, 2020000api.fda.gov
Novapproach Spine, LLCAlachua, FL, United StatesSpecification developer1September 7, 2021020api.fda.gov
NanoHive Medical LLCWoburn, MA, United StatesManufacturer, Specification developer1April 28, 2020000api.fda.gov
Osseus Fusion Systems LLCDallas, TX, United StatesSpecification developer1May 6, 2022000api.fda.gov
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer, Manufacturer, Repackager or relabeler1April 28, 2020000api.fda.gov
Omnia MedicalMorgantown, WV, United StatesSpecification developer1December 23, 2020010api.fda.gov
RSB Spine LLC.Wooster, OH, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1September 18, 2007000api.fda.gov
Signature Orthopaedics Pty LimitedSydney New South Wales, AustraliaManufacturer1November 29, 2017000api.fda.gov
Southern Medical (pty) LtdIRENE Gauteng, South AfricaComplaint file establishment, Exporter to the US, Manufacturer1October 14, 2022000api.fda.gov
Spine Wave, Inc.Shelton, CT, United StatesManufacturer, Specification developer1November 22, 2016000api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1June 10, 2026000api.fda.gov
Tyber MedicalBethlehem, PA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler1June 10, 2026000api.fda.gov
VGI medical, LLCLargo, FL, United StatesManufacturer, Specification developer1January 13, 2016010api.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 - 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
ARCH Medical Solutions - SeabrookSeabrook, NH, United StatesContract manufacturer0000api.fda.gov
Armbruster GMBHSteinach Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Autocam MedicalKentwood, MI, United StatesContract manufacturer0000api.fda.gov
Avalign Integrated Medical Solutions, IncMentor, OH, United StatesContract manufacturer0000api.fda.gov
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
Acero PrecisionWest Chester, PA, United StatesContract manufacturer0000api.fda.gov
Adcura, Inc.Wayzata, MN, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
Avalign Additive / Slice Manufacturing StudiosAkron, OH, 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
B & J Medical LLCKendallville, IN, 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
BiosealPlacentia, CA, 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
CefimecaLa Talaudiere Loire, FranceContract manufacturer0000api.fda.gov
Christian Diener GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
CREATEC GmbH & CO. KGFRIEDRICHSHAFEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
CTL Medical CorporationCarrollton, TX, United StatesComplaint file establishment, Manufacturer, Specification developer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Complexus MedicalMishawaka, IN, United StatesContract manufacturer0000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer0000api.fda.gov
Donson Machine CompanyAlsip, IL, United StatesContract manufacturer0000api.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
Euclide CareAixe Sur Vienne Haute-Vienne, FranceContract manufacturer0000api.fda.gov
Expanding Innovations, Inc.Mountain View, CA, United StatesComplaint file establishment, 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
Fong's Engineering & Manufacturing Private LimitedSingapore Central Singapore, SingaporeContract 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
Hafner Chirurgische InstrumenteBALGHEIM Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Hammill MFG. Co.Maumee, OH, United StatesContract manufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
HG Medical GmbHRaisting Bavaria, GermanyContract manufacturer0000api.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 & J Precision Technologies, LLCLititz, PA, 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
Jewel Precision Sheet Metal & Machining, Inc.Cedar Grove, NJ, 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 (Bettlach)Bettlach Solothurn, SwitzerlandContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Grenchen)Grenchen 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
LH Medical CorporationFort Wayne, IN, United StatesContract manufacturer0000api.fda.gov
Linear Precision, Inc.Florence, SC, 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
Mainstream Medical DevicesAustin, TX, United StatesContract manufacturer0000api.fda.gov
Medical Modeling - A 3D Systems CompanyLittleton, CO, United StatesContract manufacturer0000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification 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
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
Novid, LLCOxford, CT, United StatesContract manufacturer0000api.fda.gov
NextPhase Medical Devices LLCRochester, NH, 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
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Pacific Instruments Inc.Honolulu, HI, 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
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
Pro-Tech Design & MFG., Inc.Santa Fe Springs, CA, United StatesContract manufacturer0000api.fda.gov
PRO-TECH Design & Mfg, Inc.Arlington, TX, United StatesContract manufacturer0000api.fda.gov
Ptumedical GMBHSpaichingen Baden-Wurttemberg, GermanyContract 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.Smithfield, UT, United StatesContract manufacturer0000api.fda.gov
Phillips Precision IncElmwood Park, NJ, United StatesContract manufacturer0000api.fda.gov
Pioneer Surgical Technology, Inc.Marquette, MI, 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
Remel, Inc.Lenexa, KS, United StatesManufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract manufacturer0000api.fda.gov
Shandong Weigao Orthopaedic Device Co.,ltdweihai Shandong, ChinaContract manufacturer0000api.fda.gov
SimagecROUSSET CEDEX Bouches-du-Rhone, FranceContract manufacturer0000api.fda.gov
Single Source Medical LLCChurubusco, IN, United StatesContract manufacturer0000api.fda.gov
Solco Biomedical Company India Private LimitedKADI Gujarat, IndiaContract manufacturer0000api.fda.gov
Spinecraft LLCWestmont, IL, United StatesManufacturer, Specification developer0000api.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 Ireland OsteonicsCounty Cork, IrelandContract manufacturer0000api.fda.gov
Stryker SpineCESTAS Nouvelle-Aquitaine, FranceContract 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
Sterigenics U.S., LLCCorona, CA, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
Summit Orthopedic Technologies Inc.Naples, FL, 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
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
VIPER TECHNOLOGIES, LLC. (d.b.a Avalign Thortex)Parkrose, OR, United StatesContract manufacturer0000api.fda.gov
VorzeigenConnersville, IN, United StatesContract manufacturer0000api.fda.gov
Vy Spine, LLCBountiful, UT, United StatesManufacturer, Specification developer0000api.fda.gov
West-Conn Tool And Die IncShelton, CT, United StatesContract manufacturer0000api.fda.gov
Watershed Idea Foundry, Inc.Carlsbad, CA, United StatesContract manufacturer, Contract sterilizer0000api.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 September 11, 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.