Cleared Traditional

OPTI-FIX COLLARED FEMORAL COMPONENTS

K874868 · Richards Medical Co., Inc. · Orthopedic
Jan 1988
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K874868 is an FDA 510(k) clearance for the OPTI-FIX COLLARED FEMORAL COMPONENTS, a Prosthesis, Hip, Femoral Component, Cemented, Metal (Class II — Special Controls, product code JDG), submitted by Richards Medical Co., Inc. (Memphus, US). The FDA issued a Cleared decision on January 26, 1988, 60 days after receiving the submission on November 27, 1987. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K874868 FDA.gov
FDA Decision Cleared SN
Date Received November 27, 1987
Decision Date January 26, 1988
Days to Decision 60 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code JDG — Prosthesis, Hip, Femoral Component, Cemented, Metal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3360

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