DEPUY CMW 1, 2 AND 3 BONE CEMENTS— 510(k) K053003

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K053003 for DEPUY CMW 1, 2 AND 3 BONE CEMENTS, Substantially Equivalent on 2005-11-22. Applicant: DePuy Orthopaedics, Inc..

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code LOD
Advisory panel: Orthopedic
Date received: 2005-10-26
Decision date: 2005-11-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

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Adverse events under product code LOD

product code LOD

Death: 44
Injury: 3,004
Malfunction: 895
Other: 4
Total: 3,947

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.