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Data / Medical devices / Drills, Burrs, Trephines & Accessories (Compound, Powered) / United States

FDA-registered makers of Drills, Burrs, Trephines & Accessories (Compound, Powered) in the United States: 6 establishments

6 establishments in the United States are registered with the FDA to make Drills, Burrs, Trephines & Accessories (Compound, Powered) (product code HBF). 3 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.

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Device
Drills, Burrs, Trephines & Accessories (Compound, Powered)
Product code
HBF
Country
United States

Makers of Drills, Burrs, Trephines & Accessories (Compound, Powered) in the United States

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Integra LifeSciences Production CorporationMansfield, MA, United StatesManufacturer, Specification developer4January 20, 2019000api.fda.gov
Acra Cut, Inc.Acton, MA, United StatesManufacturer2December 8, 2003000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer1December 29, 2008000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
The Anspach Effort, Inc.Palm Bch Gdns, FL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov

Updated November 2, 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.