OPTI-FIX COLLARED FEMORAL COMPONENTS— 510(k) K874868

Substantially Equivalent for Some Indications

Richards Medical Co., Inc.

FDA 510(k) clearance K874868 for OPTI-FIX COLLARED FEMORAL COMPONENTS, Substantially Equivalent for Some Indications on 1988-01-26. Applicant: Richards Medical Co., Inc..

Clearance details

Applicant: Richards Medical Co., Inc.
Product code: Code JDG
Advisory panel: Orthopedic
Date received: 1987-11-27
Decision date: 1988-01-26
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Memphis, TN, 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.