PCA ACETABULAR INSERT II— 510(k) K921384

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K921384 for PCA ACETABULAR INSERT II, Substantially Equivalent on 1992-06-25. Applicant: Howmedica Corp..

Clearance details

Applicant: Howmedica Corp.
Product code: Code JDL
Advisory panel: Orthopedic
Date received: 1992-03-23
Decision date: 1992-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rutherford, NJ, US

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Adverse events under product code JDL

product code JDL

Injury: 285
Total: 285

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.