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

Drills, Burrs, Trephines & Accessories (Compound, Powered) (HBF): 13 FDA-registered makers in 6 countries

13 establishments in 6 countries are registered with the FDA to make Drills, Burrs, Trephines & Accessories (Compound, Powered) (product code HBF, Class 2, 21 CFR 882.4305). 8 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 19 510(k) clearances under this code, the latest on September 11, 2026, and lists 4 recall events (2 Class I). FDA data exported November 2, 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 every maker of this deviceMakers in the United StatesWatch this device
Product code
HBF
Device class
2
Regulation
882.4305
Medical specialty
Neurology

Makers by country

CountryMakers
United States6
Germany2
Ireland2
Hungary1
Brazil1
Switzerland1

Makers of Drills, Burrs, Trephines & Accessories (Compound, Powered)

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
Integra LifeSciences Production CorporationMansfield, MA, United StatesManufacturer, Specification developer4January 20, 2019000api.fda.gov
Acra Cut, Inc.Acton, MA, United StatesManufacturer2December 8, 2003000api.fda.gov
Adeor Medical AGValley Bavaria, GermanyComplaint file establishment, Manufacturer1July 17, 2012000api.fda.gov
Emd Endoszkop Muszer Gyarto Es Kereskedelmi KFT.Debrecen Hajdu-Bihar, HungaryManufacturer1June 20, 2022000api.fda.gov
Evonos GMBH & Co. KGTuttlingen Baden-Wurttemberg, GermanyManufacturer1March 6, 2024000api.fda.gov
Micromar Industria E Comercio LtdaSerraria, Diadema Sao Paulo, BrazilManufacturer1March 16, 2015000api.fda.gov
Stryker InstrumentsPortage, MI, United StatesComplaint file establishment, Specification developer1December 29, 2008000api.fda.gov
Stryker Ireland Ltd. Instruments Division, Innovation CentreCarrigtwohill Cork(County), IrelandSpecification developer1December 29, 2008000api.fda.gov
Millstone Medical Outsourcing LLCOlive Branch, MS, United StatesContract manufacturer0000api.fda.gov
Orchid UniqueBridgeport, MI, United StatesContract manufacturer0000api.fda.gov
Stryker Ireland Ltd., Instruments DivisionCARRIGTWOHILL, CO.CORK Munster, IrelandContract manufacturer0000api.fda.gov
Synthes GMBHZuchwil Solothurn, SwitzerlandSpecification developer0000api.fda.gov
The Anspach Effort, Inc.Palm Bch Gdns, FL, United StatesComplaint file establishment, Manufacturer0000api.fda.gov

Updated September 11, 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.