DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS— 510(k) K053536

Substantially Equivalent

Zimmer GmbH

FDA 510(k) clearance K053536 for DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS, Substantially Equivalent on 2006-03-16. Applicant: Zimmer GmbH.

Clearance details

Applicant: Zimmer GmbH
Product code: Code KWA
Advisory panel: Orthopedic
Date received: 2005-12-19
Decision date: 2006-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code KWA

product code KWA

Death: 38
Injury: 10,439
Malfunction: 1,862
Total: 12,339

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.