Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve— 510(k) K212431

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K212431 for Biomet Answer/Impact/Integral Distal Centralizer/Centering Sleeve, Substantially Equivalent on 2022-02-07. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code JDG
Advisory panel: Orthopedic
Date received: 2021-08-04
Decision date: 2022-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code JDG

product code JDG

Injury: 804
Malfunction: 3,242
Total: 4,046

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.