IMPACT CO-CR 1-PIECE FEMORAL COMPONENT— 510(k) K942027

Substantially Equivalent for Some Indications

Biomet, Inc.

FDA 510(k) clearance K942027 for IMPACT CO-CR 1-PIECE FEMORAL COMPONENT, Substantially Equivalent for Some Indications on 1994-09-19. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code JDG
Advisory panel: Orthopedic
Date received: 1994-04-26
Decision date: 1994-09-19
Decision: Substantially Equivalent for Some Indications
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.