MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD— 510(k) K042321

Name: FDA 510(k) clearance K042321
Creator: U.S. Food and Drug Administration
Published: 2005-01-28

Substantially Equivalent

Biomet Manufacturing Corp

FDA 510(k) clearance K042321 for MOSAIC NON-MODULAR PROXIMAL BODY AND EAS OFFSET MODULAR HUMERAL HEAD, Substantially Equivalent on 2005-01-28. Applicant: Biomet Manufacturing Corp. Device class: 2.

Clearance details

Applicant: Biomet Manufacturing Corp
Product code: Code KWT
Device class: Class 2
Regulation: 21 CFR 888.3650
Advisory panel: Orthopedic
Date received: 2004-08-26
Decision date: 2005-01-28
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 KWT

product code KWT

Injury: 2,467
Other: 2
Total: 2,469

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.