EXACTECH HUMERAL SHOULDER PROSTHESIS— 510(k) K905577

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K905577 for EXACTECH HUMERAL SHOULDER PROSTHESIS, Substantially Equivalent on 1991-03-12. Applicant: Exactech, Inc..

Clearance details

Applicant: Exactech, Inc.
Product code: Code HSD
Advisory panel: Orthopedic
Date received: 1990-12-12
Decision date: 1991-03-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

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Adverse events under product code HSD

product code HSD

Injury: 3,425
Malfunction: 531
Total: 3,956

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.