P.S.A. FEMORAL HIP PROSTHESIS— 510(k) K893959

Substantially Equivalent

Protek, Inc.

FDA 510(k) clearance K893959 for P.S.A. FEMORAL HIP PROSTHESIS, Substantially Equivalent on 1989-07-25. Applicant: Protek, Inc..

Clearance details

Applicant: Protek, Inc.
Product code: Code KWY
Advisory panel: Orthopedic
Date received: 1989-06-01
Decision date: 1989-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KWY

product code KWY

Death: 3
Injury: 2,049
Total: 2,052

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.