P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL— 510(k) K914439

Substantially Equivalent

Johnson & Johnson Orthopaedics, Inc.

FDA 510(k) clearance K914439 for P.F.C.(TM) UNICONDYLAR KNEE SYST, POR COAT FEMORAL, Substantially Equivalent on 1991-10-23. Applicant: Johnson & Johnson Orthopaedics, Inc..

Clearance details

Applicant: Johnson & Johnson Orthopaedics, Inc.
Product code: Code HSX
Advisory panel: Orthopedic
Date received: 1991-10-04
Decision date: 1991-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

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Adverse events under product code HSX

product code HSX

Injury: 1,003
Other: 1
Total: 1,004

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.