CHARNLEY DESIGN HIP PROSTHESIS— 510(k) K801006

Substantially Equivalent

Colmed, Ltd.

FDA 510(k) clearance K801006 for CHARNLEY DESIGN HIP PROSTHESIS, Substantially Equivalent on 1980-05-20. Applicant: Colmed, Ltd..

Clearance details

Applicant: Colmed, Ltd.
Product code: Code JDG
Advisory panel: Orthopedic
Date received: 1980-04-28
Decision date: 1980-05-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.