FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM— 510(k) K980713

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K980713 for FEMORAL AND TIBIAL PLUGS OF INTERAX TOTAL KNEE SYSTEM, Substantially Equivalent on 1998-05-22. Applicant: Howmedica Corp..

Clearance details

Applicant: Howmedica Corp.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 1998-02-24
Decision date: 1998-05-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rutherford, 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.