CONSENSUS(TM) KNEE COBALT CHROME NONPOROUS STEMMED TIBIAL BASEPLATE— 510(k) K945589

Substantially Equivalent

U.S. Medical Products, Inc.

FDA 510(k) clearance K945589 for CONSENSUS(TM) KNEE COBALT CHROME NONPOROUS STEMMED TIBIAL BASEPLATE, Substantially Equivalent on 1995-05-31. Applicant: U.S. Medical Products, Inc..

Clearance details

Applicant: U.S. Medical Products, Inc.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 1994-11-14
Decision date: 1995-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, 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.