OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY— 510(k) K954208

Substantially Equivalent for Some Indications

Exactech, Inc.

FDA 510(k) clearance K954208 for OPTETRAK CONSTRAINED CONDYLAR KNEE FOR CEMENTED USE ONLY, Substantially Equivalent for Some Indications on 1996-02-26. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code JWH
Advisory panel: Orthopedic
Date received: 1995-09-07
Decision date: 1996-02-26
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Gainesville, FL, 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.