DEPUY AMK ALL POLYETHYLENE POSTERIOR STABLILIZED TIBIAL TRAY— 510(k) K943299

Substantially Equivalent for Some Indications

Depuy, Inc.

FDA 510(k) clearance K943299 for DEPUY AMK ALL POLYETHYLENE POSTERIOR STABLILIZED TIBIAL TRAY, Substantially Equivalent for Some Indications on 1995-01-27. Applicant: Depuy, Inc..

Clearance details

Applicant: Depuy, Inc.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 1994-07-09
Decision date: 1995-01-27
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Warsaw, IN, 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.