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Data / Medical devices / Plate, Cranioplasty, Preformed, Non-Alterable / United States

FDA-registered makers of Plate, Cranioplasty, Preformed, Non-Alterable in the United States: 18 establishments

18 establishments in the United States are registered with the FDA to make Plate, Cranioplasty, Preformed, Non-Alterable (product code GXN). 11 have a 510(k) clearance or PMA approval on file and 3 have a recall event. FDA data exported November 3, 2026.

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Device
Plate, Cranioplasty, Preformed, Non-Alterable
Product code
GXN
Country
United States

Makers of Plate, Cranioplasty, Preformed, Non-Alterable in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Longeviti Neuro SolutionsBaltimore, MD, United StatesComplaint file establishment, Manufacturer7June 25, 2026000api.fda.gov
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Manufacturer, Specification developer5November 12, 2025010api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer4November 10, 2025000api.fda.gov
Kelyniam Global Inc.Collinsville, CT, United StatesManufacturer2September 25, 2012010api.fda.gov
MedCADPlano, TX, United StatesManufacturer2August 26, 2022000api.fda.gov
Oxford Performance Materials, Inc.South Windsor, CT, United StatesComplaint file establishment, Manufacturer2July 27, 2018000api.fda.gov
VanDuzen, Inc. dba MedCADDallas, TX, United StatesManufacturer, Repackager or relabeler2August 26, 2022000api.fda.gov
3D Medical Applications Center (3D Mac)Bethesda, MD, United StatesManufacturer1June 18, 2026000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesSpecification developer1May 21, 2003000api.fda.gov
Bioplate, Inc.Placentia, CA, United StatesComplaint file establishment, Manufacturer1October 28, 2022000api.fda.gov
OsteomedAddison, TX, United StatesManufacturer1April 1, 2003000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesContract manufacturer0010api.fda.gov
Culver Tool & EngineeringPlymouth, 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
KLS Martin Manufacturing, LLCJacksonville, FL, United StatesContract manufacturer0000api.fda.gov
Medtronic NeurosurgeryFort Worth, TX, United StatesSpecification developer0000api.fda.gov
Viant AS&O Holdings, LLCBrimfield, MA, United StatesContract manufacturer0000api.fda.gov

Updated November 3, 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.