DEPUY PRESERVATION UNICONDYLAR TIBIA— 510(k) K040268

Substantially Equivalent

DePuy Orthopaedics, Inc.

FDA 510(k) clearance K040268 for DEPUY PRESERVATION UNICONDYLAR TIBIA, Substantially Equivalent on 2004-05-05. Applicant: DePuy Orthopaedics, Inc..

Clearance details

Applicant: DePuy Orthopaedics, Inc.
Product code: Code HRY
Advisory panel: Orthopedic
Date received: 2004-02-05
Decision date: 2004-05-05
Decision: Substantially Equivalent
Clearance type: Special
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

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.