BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL— 510(k) K091976

Substantially Equivalent

Biomet Trauma

FDA 510(k) clearance K091976 for BIOMET PHOENIX ANKLE NAIL AND ANKLE ARTHRODESIS NAIL, Substantially Equivalent on 2009-08-17. Applicant: Biomet Trauma.

Clearance details

Applicant: Biomet Trauma
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2009-07-01
Decision date: 2009-08-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

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Adverse events under product code HSB

product code HSB

Death: 49
Injury: 12,083
Malfunction: 6,561
Other: 1
Total: 18,694

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.