CO-CR ANSWER FEMORAL COMPONENT— 510(k) K931194

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K931194 for CO-CR ANSWER FEMORAL COMPONENT, Substantially Equivalent on 1994-05-05. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code JDG
Advisory panel: Orthopedic
Date received: 1993-03-09
Decision date: 1994-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, US

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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.