EXACTECH FEMORAL STEM— 510(k) K925201

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K925201 for EXACTECH FEMORAL STEM, Substantially Equivalent on 1993-06-15. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code JDI
Advisory panel: Orthopedic
Date received: 1992-10-16
Decision date: 1993-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

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Adverse events under product code JDI

product code JDI

Death: 65
Injury: 12,943
Malfunction: 1,681
Total: 14,689

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.