G7 ACETABULAR SYSTEM— 510(k) K121874

Substantially Equivalent

Biomet Manufacturing Corp

FDA 510(k) clearance K121874 for G7 ACETABULAR SYSTEM, Substantially Equivalent on 2012-11-23. Applicant: Biomet Manufacturing Corp.

Clearance details

Applicant: Biomet Manufacturing Corp
Product code: Code PBI
Advisory panel: Orthopedic
Date received: 2012-06-27
Decision date: 2012-11-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code PBI

product code PBI

Injury: 499
Malfunction: 729
Total: 1,228

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.