EXACTECH OPTETRAK UNICONDYLAR KNEE— 510(k) K040889

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K040889 for EXACTECH OPTETRAK UNICONDYLAR KNEE, Substantially Equivalent on 2004-10-01. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code HRY
Advisory panel: Orthopedic
Date received: 2004-04-05
Decision date: 2004-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

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Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

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.