OMNIFIT TOTAL KNEE SERIES III,IV & POST. STAB. FEM— 510(k) K884410

Substantially Equivalent for Some Indications

Osteonics Corp.

FDA 510(k) clearance K884410 for OMNIFIT TOTAL KNEE SERIES III,IV & POST. STAB. FEM, Substantially Equivalent for Some Indications on 1989-01-18. Applicant: Osteonics Corp..

Clearance details

Applicant: Osteonics Corp.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 1988-10-20
Decision date: 1989-01-18
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Allendale, 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.