LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE— 510(k) K012551

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K012551 for LIVERPOOL RADIAL HEAD REPLACEMENT DEVICE, Substantially Equivalent on 2002-01-30. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code KWI
Advisory panel: Orthopedic
Date received: 2001-08-07
Decision date: 2002-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code KWI

product code KWI

Injury: 490
Total: 490

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.