FEMORAL CEMENT RESTRICTOR— 510(k) K800144

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K800144 for FEMORAL CEMENT RESTRICTOR, Substantially Equivalent on 1980-02-19. Applicant: Biomet, Inc..

Clearance details

Applicant: Biomet, Inc.
Product code: Code JDS
Advisory panel: Orthopedic
Date received: 1980-01-21
Decision date: 1980-02-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code JDS

product code JDS

Injury: 1,776
Malfunction: 1,509
Total: 3,285

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.