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Data / Medical devices / System, Facet Screw Spinal Device

System, Facet Screw Spinal Device (MRW): 88 FDA-registered makers in 9 countries

88 establishments in 9 countries are registered with the FDA to make System, Facet Screw Spinal Device (product code MRW, Class U). 36 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 79 510(k) clearances under this code, the latest on September 24, 2026, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code
MRW
Device class
U
Medical specialty
Unknown
Implant
Yes

Makers by country

CountryMakers
United States71
France6
Switzerland3
South Korea2
Costa Rica2
Israel1
Germany1
Italy1
India1

Makers of System, Facet Screw Spinal Device

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
Surgentec LLCBoca Raton, FL, United StatesManufacturer6June 11, 2026000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesSpecification developer4October 22, 2010000api.fda.gov
Providence Medical Technology, Inc.Pleasanton, CA, United StatesComplaint file establishment, Manufacturer, Specification developer4May 14, 2026000api.fda.gov
Globus Medical, Inc.Audubon, PA, United StatesManufacturer, Manufacturer for export3December 16, 2019000api.fda.gov
Globus Medical, Inc.Memphis, TN, United StatesManufacturer3July 15, 2010000api.fda.gov
Highridge Medical, LLCWestminster, CO, United StatesSpecification developer3August 4, 2016000api.fda.gov
Medos International SarlLe Locle Neuchatel, SwitzerlandSpecification developer3November 20, 2019000api.fda.gov
Medtronic Puerto Rico Operations Co., HumacaoHumacao, PR, United StatesManufacturer3July 24, 2002000api.fda.gov
Spinal Elements, Inc.Carlsbad, CA, United StatesComplaint file establishment, Manufacturer3May 21, 2025000api.fda.gov
Warsaw Orthopedic, Inc.Warsaw, IN, United StatesManufacturer3July 24, 2002000api.fda.gov
Arthrex, Inc.Naples, FL, United StatesSpecification developer2September 24, 2026000api.fda.gov
Choice Spine LLCKnoxville, TN, United StatesComplaint file establishment, Specification developer2September 20, 2012000api.fda.gov
Depuy Spine, Inc.Raynham, MA, United StatesSpecification developer2November 15, 2010000api.fda.gov
LDR MedicalSainte-Savine Aube, FranceSpecification developer2August 4, 2016000api.fda.gov
Nuvasive, Inc.San Diego, CA, United StatesManufacturer2July 15, 2010000api.fda.gov
SC MedicaStrasbourg Bas-Rhin, FranceComplaint file establishment, Manufacturer, Specification developer2October 16, 2025000api.fda.gov
SpineSmith Holdings, LLCAustin, TX, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer2April 28, 2015000api.fda.gov
TranS1Magnolia, TX, United StatesComplaint file establishment, Specification developer2March 11, 2008000api.fda.gov
Xtant Medical Holdings, Inc.Belgrade, MT, United StatesRepackager or relabeler, Specification developer2May 1, 2013000api.fda.gov
ZygoFixD.N. Misgav Northern, IsraelManufacturer2September 20, 2024000api.fda.gov
Alphatec Spine, Inc.Carlsbad, CA, United StatesManufacturer, Specification developer1November 28, 2012000api.fda.gov
Alphatec Spine, Inc.Memphis, TN, United StatesManufacturer1November 28, 2012000api.fda.gov
CG MedTech Co., Ltd.Uijeongbu-si Gyeonggi, South KoreaManufacturer1January 3, 2018000api.fda.gov
Medtronic Sofamor Danek Usa, Inc.Memphis, TN, United StatesManufacturer1October 22, 2010010api.fda.gov
Medtronic Medical Costa Rica S.R.L.Coyol Alajuela, Costa RicaManufacturer1January 17, 2001000api.fda.gov
Nexxt Spine LLCNoblesville, IN, United StatesComplaint file establishment, Manufacturer1July 12, 2013000api.fda.gov
Nuvasive, Inc.Guaynabo, PR, United StatesManufacturer1March 12, 2002000api.fda.gov
Organ Eco TechSeongnam-Si Gyeonggi, South KoreaManufacturer1June 28, 2018000api.fda.gov
Precision Spine, Inc.Pearl, MS, United StatesManufacturer1August 9, 2013000api.fda.gov
Seaspine Orthopedics CorporationCarlsbad, CA, United StatesComplaint file establishment, Manufacturer, Specification developer1November 18, 2013000api.fda.gov
Spineology Inc.Saint Paul, MN, United StatesManufacturer1November 9, 2009000api.fda.gov
Stryker SpineAllendale, NJ, United StatesComplaint file establishment, Manufacturer, Specification developer1August 22, 2003000api.fda.gov
Synthes GMBHSelzach Solothurn, SwitzerlandManufacturer1November 15, 2010000api.fda.gov
Vy Spine, LLCBountiful, UT, United StatesManufacturer, Specification developer1March 19, 2026000api.fda.gov
Wenzel SpineAustin, TX, United StatesSpecification developer1September 30, 2010000api.fda.gov
ZavationFlowood, MS, United StatesComplaint file establishment, Manufacturer1October 28, 2013000api.fda.gov
Arch Medical Solutions - Philadelphia, LLC Dba Jade Precision Medical ComponentsHuntingdon Valley, PA, United StatesContract manufacturer0000api.fda.gov
ARCH Medical Solutions - SeabrookSeabrook, NH, United StatesContract manufacturer0000api.fda.gov
Axial MedicalIvyland, PA, United StatesContract manufacturer0000api.fda.gov
Acero PrecisionWest Chester, PA, United StatesContract manufacturer0000api.fda.gov
Arthrex Manufacturing Inc.Pendleton, SC, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Arthrex, Inc.Ave Maria, FL, United StatesContract manufacturer, Contract sterilizer0000api.fda.gov
Autocam MedicalMurfreesboro, TN, United StatesContract manufacturer0000api.fda.gov
B & G MFG. Co.Hatfield, PA, 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
Biomerics AlajuelaAlajuela, Costa RicaContract manufacturer0000api.fda.gov
Bradshaw Medical Inc.Kenosha, WI, United StatesContract manufacturer0000api.fda.gov
Culver Tool & EngineeringPlymouth, IN, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCBartlett, TN, United StatesContract manufacturer0000api.fda.gov
Elite Medical, LLCCordova, TN, United StatesContract manufacturer0000api.fda.gov
First Article IncSouderton, PA, United StatesContract manufacturer0000api.fda.gov
Harwood Design, Inc.Bristol, PA, United StatesContract manufacturer0000api.fda.gov
Hipp Medical AGRenquishausen Baden-Wurttemberg, GermanyContract manufacturer0000api.fda.gov
Instru-Med TechnologiesWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Jabil Switzerland Manufacturing GmbH (Le Locle)Le Locle Neuchatel, SwitzerlandContract manufacturer0000api.fda.gov
Lincotek Bologna S.R.L.Cadriano di Granarolo, Bologna, ItalyContract manufacturer0000api.fda.gov
LISI MEDICAL REmmeleBig Lake, MN, 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
Maitland EngineeringSouth Bend, IN, United StatesContract manufacturer0000api.fda.gov
Micropulse IncColumbia City, IN, 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
Neuro France ImplantsLa Ville-aux-Clercs Loir-et-Cher, FranceContract manufacturer0000api.fda.gov
Ngage Medical ManufacturingHernando, MS, United StatesContract manufacturer0000api.fda.gov
NGInstruments, Inc dba Avalign Cutting InstrumentsWarsaw, IN, United StatesContract manufacturer0000api.fda.gov
Oberg Medical Products CompanySarver, PA, United StatesContract manufacturer0000api.fda.gov
Onyx Medical LLCMemphis, TN, United StatesContract manufacturer0000api.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 - DaytonDayton, OH, United StatesContract 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
SimagecROUSSET CEDEX Bouches-du-Rhone, FranceContract manufacturer0000api.fda.gov
Solco Biomedical Company India Private LimitedKADI Gujarat, IndiaContract manufacturer0000api.fda.gov
SPINEFRONTIER, INC. DBA LESspine InnovationsBurlington, MA, United StatesManufacturer0000api.fda.gov
Stryker SpineCESTAS Nouvelle-Aquitaine, FranceContract manufacturer0000api.fda.gov
Safe MedicalFleurieux-Sur-L'Arbresle Rhone, FranceContract manufacturer0000api.fda.gov
Turner Medical Inc.Athens, AL, United StatesContract manufacturer0000api.fda.gov
Tech Industries. Inc.Cleveland, OH, United StatesContract manufacturer0000api.fda.gov
VorzeigenConnersville, IN, United StatesContract manufacturer0000api.fda.gov
Viant Fremont, IncFremont, CA, United StatesContract manufacturer0000api.fda.gov
Zigg Design LLCNibley, UT, United StatesContract manufacturer0000api.fda.gov

Updated September 24, 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.