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Data / Medical devices / Posterior Metal/Polymer Spinal System, Fusion

Posterior Metal/Polymer Spinal System, Fusion (NQP): 34 FDA-registered makers in 5 countries

34 establishments in 5 countries are registered with the FDA to make Posterior Metal/Polymer Spinal System, Fusion (product code NQP, Class 2, 21 CFR 888.3070). 9 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 22 510(k) clearances under this code, the latest on January 15, 2021, and lists 5 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
NQP
Device class
2
Regulation
888.3070
Medical specialty
Orthopedic
Implant
Yes

Makers by country

CountryMakers
United States26
China3
Germany2
Switzerland2
Costa Rica1

Makers of Posterior Metal/Polymer Spinal System, Fusion

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
Medtronic Puerto Rico Operations Co., HumacaoHumacao, PR, United StatesManufacturer3January 15, 2021000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer3January 15, 2021010api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer3January 15, 2021000api.fda.gov
Medtronic Sofamor Danek Deggendorf GMBHDEGGENDORF Bavaria, GermanyManufacturer2October 3, 2019000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer2January 15, 2021000api.fda.gov
Medtronic Medical Costa Rica S.R.L.Coyol Alajuela, Costa RicaManufacturer2January 15, 2021000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer, Manufacturer for export1February 20, 2009000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer1February 20, 2009000api.fda.gov
Medtronic Xomed, Inc.Jacksonville, FL, United StatesManufacturer1January 11, 2019000api.fda.gov
APS Materials SuzhouSuzhou Jiangsu, ChinaContract manufacturer0000api.fda.gov
ARCH Medical Solutions - Olive BranchOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
B & G MFG. Co.Hatfield, PA, United StatesContract manufacturer0000api.fda.gov
Baechler Feintech AGHoelstein Basel-Landschaft, SwitzerlandContract 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
Cep Bio-Coat, LLCFarmington Hills, MI, United StatesContract manufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Eptam Plastics, LtdNorthfield, NH, 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
First Article IncSouderton, PA, United StatesContract manufacturer0000api.fda.gov
Flex-Cell Precision, Inc.Lancaster, PA, United StatesContract manufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Medtronic (Changzhou) Medical Devices Technology Co., LtdChangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Metal Craft Machine & Engineering, Inc.Elk River, MN, United StatesContract manufacturer0000api.fda.gov
Orchid Orthopedic Solutions Alabama LLCArab, AL, United StatesContract manufacturer0000api.fda.gov
Riverside Machine & Engineering, Inc.Eau Claire, WI, United StatesContract manufacturer0000api.fda.gov
Samaplast AGSankt Margrethen Sankt Gallen, SwitzerlandContract manufacturer0000api.fda.gov
Shandong Weigao Orthopaedic Device Co.,ltdweihai Shandong, ChinaContract manufacturer0000api.fda.gov
Victoria Precision Inc.Trevose, PA, United StatesContract manufacturer0000api.fda.gov
Vaupell Midwest Molding and ToolingConstantine, MI, United StatesContract manufacturer0000api.fda.gov

Updated January 15, 2021. 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.