BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831— 510(k) K122770

Substantially Equivalent

Biomet Manufacturing Corp

FDA 510(k) clearance K122770 for BIOMET RECONSTRUCTIVE WEDGES MODEL 110003660-99, 110003797-831, Substantially Equivalent on 2013-03-28. Applicant: Biomet Manufacturing Corp.

Clearance details

Applicant: Biomet Manufacturing Corp
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2012-09-10
Decision date: 2013-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.