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Data / Medical devices / Orthosis, Spine, Plate, Laminoplasty, Metal

Orthosis, Spine, Plate, Laminoplasty, Metal (NQW): 67 FDA-registered makers in 7 countries

67 establishments in 7 countries are registered with the FDA to make Orthosis, Spine, Plate, Laminoplasty, Metal (product code NQW, Class 2, 21 CFR 888.3050). 24 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 30 510(k) clearances under this code, the latest on May 27, 2026, and lists 0 recall events (0 Class I). FDA data exported November 3, 2026.

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Product code
NQW
Device class
2
Regulation
888.3050
Medical specialty
Orthopedic
Implant
Yes

Makers by country

CountryMakers
United States56
Switzerland4
Malaysia3
Costa Rica1
China1
Germany1
France1

Makers of Orthosis, Spine, Plate, Laminoplasty, Metal

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.Audubon, PA, United StatesManufacturer3July 14, 2017000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer2July 3, 2019000api.fda.gov
Life SpineHuntley, IL, United StatesSpecification developer2September 20, 2019000api.fda.gov
Medtronic Puerto Rico Operations Co., HumacaoHumacao, PR, United StatesManufacturer2December 13, 2021000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer2December 13, 2021000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer2December 13, 2021000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2July 3, 2019000api.fda.gov
Seaspine Orthopedics CorporationCarlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer2March 23, 2015000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer2January 7, 2010000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer2January 7, 2010000api.fda.gov
Vy Spine, LLCBountiful, UT, United StatesManufacturer, Specification developer2October 16, 2024000api.fda.gov
Curiteva, Inc.Tanner, AL, United StatesManufacturer1June 28, 2023000api.fda.gov
Choice Spine LLCKnoxville, TN, United StatesComplaint file establishment, Specification developer1January 19, 2018000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer1January 7, 2010000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer1July 20, 2010000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer1January 7, 2010000api.fda.gov
Medtronic Medical Costa Rica S.R.L.Coyol Alajuela, Costa RicaManufacturer1June 6, 2005000api.fda.gov
Nuvasive, Inc.Guaynabo, PR, United StatesManufacturer1July 3, 2019000api.fda.gov
Orthofix Us LLCLewisville, TX, United StatesComplaint file establishment, Manufacturer, Specification developer1February 18, 2005000api.fda.gov
Stryker SpineAllendale, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer1April 16, 2012000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesSpecification developer1April 1, 2004000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer1June 6, 2005000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesSpecification developer1March 15, 2016000api.fda.gov
Zhejiang Decans Medical Devices Co.,ltd.Jiaxing Zhejiang, ChinaManufacturer1May 27, 2026000api.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
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
B & G MFG. Co.Hatfield, PA, United StatesContract manufacturer0000api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer0000api.fda.gov
Christian Diener GMBHTUTTLINGEN Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, 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
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, 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
Jabil Inc. (Elmira)Horseheads, NY, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Mezzovico)Mezzovico Ticino, SwitzerlandContract manufacturer0000api.fda.gov
Lowell,inc.Brooklyn Park, MN, United StatesContract manufacturer0000api.fda.gov
Mackay Manufacturing, Inc.Spokane Valley, WA, United StatesContract manufacturer0000api.fda.gov
Millstone Medical Outsourcing LLC.Fall River, MA, 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
Olive Branch Distribution CenterOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Precision Forms, Inc.Butler, NJ, United StatesContract manufacturer0000api.fda.gov
Paragon Medical - DaytonDayton, OH, United StatesContract manufacturer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
RMS Co.Minneapolis, MN, United StatesContract 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
Sterigenics US, LLCLewis Center, OH, United StatesContract sterilizer, Manufacturer for export0000api.fda.gov
Structure Medical, LLC.Mooresville, NC, United StatesContract manufacturer0000api.fda.gov
TOMZ CorporationBerlin, CT, United StatesContract manufacturer0000api.fda.gov
Victoria Precision Inc.Trevose, PA, United StatesContract manufacturer0000api.fda.gov
VorzeigenConnersville, IN, United StatesContract manufacturer0000api.fda.gov
Wheelhouse MedicalMonroe, NC, United StatesContract manufacturer0000api.fda.gov
Zigg Design LLCNibley, UT, United StatesContract manufacturer0000api.fda.gov

Updated May 27, 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.