OPTEON UNIPOLAR— 510(k) K960538

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K960538 for OPTEON UNIPOLAR, Substantially Equivalent on 1996-03-27. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code KWL
Advisory panel: Orthopedic
Date received: 1996-02-07
Decision date: 1996-03-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

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Adverse events under product code KWL

product code KWL

Injury: 523
Total: 523

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.