EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM— 510(k) K921113

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K921113 for EXATECH MCS POROUS COATED TOTAL HIP FEMORAL STEM, Substantially Equivalent on 1993-10-27. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code LPH
Advisory panel: Orthopedic
Date received: 1992-03-09
Decision date: 1993-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

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Adverse events under product code LPH

product code LPH

Death: 73
Injury: 31,640
Malfunction: 3,358
Other: 2
Total: 35,073

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.