M2A 32MM TAPER SYSTEM— 510(k) K003363

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K003363 for M2A 32MM TAPER SYSTEM, Substantially Equivalent on 2000-12-15. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 2000-10-27
Decision date: 2000-12-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.