PCA (R) TIBIAL BONE WEDGES— 510(k) K904170

Substantially Equivalent for Some Indications

Howmedica Corp.

FDA 510(k) clearance K904170 for PCA (R) TIBIAL BONE WEDGES, Substantially Equivalent for Some Indications on 1990-10-17. Applicant: Howmedica Corp..

Clearance details

Applicant: Howmedica Corp.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 1990-09-11
Decision date: 1990-10-17
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Rutherford, NJ, US

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Adverse events under product code JWH

product code JWH

Death: 26
Injury: 51,564
Malfunction: 9,725
Other: 9
Total: 61,324

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.