Skip to the page
Get started free

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

FDA-registered makers of Plate, Cranioplasty, Preformed, Alterable in the United States: 19 establishments

19 establishments in the United States are registered with the FDA to make Plate, Cranioplasty, Preformed, Alterable (product code GWO). 10 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 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 makers of this device in the United StatesWatch these makers
Device
Plate, Cranioplasty, Preformed, Alterable
Product code
GWO
Country
United States

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

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Synthes (USA) Products LLCWest Chester, PA, United StatesComplaint file establishment, Specification developer4June 13, 2014000api.fda.gov
INNO Holdings Inc.Millcreek, UT, United StatesManufacturer, Repackager or relabeler2November 7, 2014000api.fda.gov
Kelyniam Global Inc.Collinsville, CT, United StatesManufacturer2July 25, 2025000api.fda.gov
Acumed LLCHillsboro, OR, United StatesManufacturer1October 27, 2025000api.fda.gov
Biomet MicrofixationJacksonville, FL, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1October 12, 2012010api.fda.gov
Kinamed, Inc.Camarillo, CA, United StatesManufacturer1April 5, 2013000api.fda.gov
KLS-Martin L.P.Jacksonville, FL, United StatesSpecification developer1January 17, 2013000api.fda.gov
Mci Medical Concept Innovation Inc.Sunrise, FL, United StatesManufacturer1October 21, 2022000api.fda.gov
Medical Modeling - A 3D Systems CompanyLittleton, CO, United StatesManufacturer1April 4, 2024000api.fda.gov
OsteomedAddison, TX, United StatesContract manufacturer, Manufacturer1August 15, 2011010api.fda.gov
3D Medical Applications Center (3D Mac)Bethesda, MD, United StatesManufacturer0000api.fda.gov
Biomet, Inc.Warsaw, IN, United StatesContract manufacturer0000api.fda.gov
DSM Biomedical, Inc.Exton, PA, United StatesContract manufacturer0000api.fda.gov
Howmedica Osteonics CorpMahwah, NJ, United StatesManufacturer0000api.fda.gov
Jabil Inc. (Brandywine)W Chester, PA, United StatesContract manufacturer0000api.fda.gov
Jabil Inc. (Monument)Monument, CO, United StatesContract manufacturer0000api.fda.gov
Neurovention, LLCDaytona Beach, FL, United StatesSpecification developer0000api.fda.gov
Quality Tech Services, LLCBloomington, MN, United StatesContract manufacturer0000api.fda.gov
TecometWoburn, 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.