BME BONE DRILL BITS— 510(k) K964073

Name: FDA 510(k) clearance K964073
Creator: U.S. Food and Drug Administration
Published: 1996-11-14

Substantially Equivalent

Biomedical Ent., Inc.

FDA 510(k) clearance K964073 for BME BONE DRILL BITS, Substantially Equivalent on 1996-11-14. Applicant: Biomedical Ent., Inc.. Device class: 1.

Clearance details

Applicant: Biomedical Ent., Inc.
Product code: Code GEY
Device class: Class 1
Regulation: 21 CFR 878.4820
Advisory panel: General, Plastic Surgery
Date received: 1996-10-11
Decision date: 1996-11-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Antonio, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code GEY

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K050519 — ADVANCED TURBO DRIVE SYSTEM2005-05-17
K020621 — ARTHROCARE CONTROLLER; ARTHROCARE CABLE; FOOT CONTROL; POWER CORD; WANDS2002-03-28
K012738 — SYMPHONY GRAFT DELIVERY SYSTEM (GDS)2001-11-14
K972308 — MEDNEXT 1000 DRILL1997-08-20
K971941 — AQUA SPRAY1997-08-14

More clearances from Biomedical Ent., Inc.

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K133844 — SPEED TRIAD2014-04-07
K133780 — SPEED XL2014-03-19
K131640 — SMOOTH OR THREADED METALLIC BONE FASTENER2013-10-16
K102107 — OSSTAPLE CHILL2010-09-03
K091951 — HAMMERLOCK2010-02-19

Adverse events under product code GEY

product code GEY

Malfunction: 7,488
Total: 7,488

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.