OSTEOTOMES FOR CUTTING BONH— 510(k) K771744

Name: FDA 510(k) clearance K771744
Creator: U.S. Food and Drug Administration
Published: 1977-09-28

Substantially Equivalent

Depuy, Inc.

FDA 510(k) clearance K771744 for OSTEOTOMES FOR CUTTING BONH, Substantially Equivalent on 1977-09-28. Applicant: Depuy, Inc.. Device class: 1.

Clearance details

Applicant: Depuy, Inc.
Product code: Code HWM
Device class: Class 1
Regulation: 21 CFR 878.4800
Advisory panel: General, Plastic Surgery
Date received: 1977-09-15
Decision date: 1977-09-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

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K874503 — MICRO-AIRE OSTEOTOME SYSTEM OR BONE HARVESTER1987-12-02
K870780 — ACROMED WALLIE-HEINIG OSTEOTOMES1987-03-09

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Adverse events under product code HWM

product code HWM

Other: 1
Total: 1

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.