OSTEONICS 7000 POSTERIOR STAB. TOTAL KNEE FEM. COM— 510(k) K914565

Substantially Equivalent

Osteonics Corp.

FDA 510(k) clearance K914565 for OSTEONICS 7000 POSTERIOR STAB. TOTAL KNEE FEM. COM, Substantially Equivalent on 1992-05-15. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 1991-10-15
Decision date: 1992-05-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allendale, NJ, US

Download summary PDF View on FDA.gov ↗

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.