VERSA-DIAL HUMERAL HEAD— 510(k) K040610

Name: FDA 510(k) clearance K040610
Creator: U.S. Food and Drug Administration
Published: 2004-06-04

Substantially Equivalent

Biomet Manufacturing, Inc.

FDA 510(k) clearance K040610 for VERSA-DIAL HUMERAL HEAD, Substantially Equivalent on 2004-06-04. Applicant: Biomet Manufacturing, Inc.. Device class: 2.

Clearance details

Applicant: Biomet Manufacturing, Inc.
Product code: Code KWS
Device class: Class 2
Regulation: 21 CFR 888.3660
Advisory panel: Orthopedic
Date received: 2004-03-08
Decision date: 2004-06-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code KWS

product code KWS

Death: 6
Injury: 9,652
Malfunction: 1,385
Other: 1
Total: 11,044

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.