BIOMET FEMORAL LOCKING NAIL SYSTEM— 510(k) K072161

Substantially Equivalent

Biomet Manufacturing Corp

FDA 510(k) clearance K072161 for BIOMET FEMORAL LOCKING NAIL SYSTEM, Substantially Equivalent on 2007-09-20. Applicant: Biomet Manufacturing Corp.

Clearance details

Applicant: Biomet Manufacturing Corp
Product code: Code HSB
Advisory panel: Orthopedic
Date received: 2007-08-06
Decision date: 2007-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

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.