Cleared Traditional

CHARNLEY DESIGN HIP PROSTHESIS

K801006 · Colmed, Ltd. · Orthopedic
May 1980
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K801006 is an FDA 510(k) clearance for the CHARNLEY DESIGN HIP PROSTHESIS, a Prosthesis, Hip, Femoral Component, Cemented, Metal (Class II — Special Controls, product code JDG), submitted by Colmed, Ltd. (Walker, US). The FDA issued a Cleared decision on May 20, 1980, 22 days after receiving the submission on April 28, 1980. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K801006 FDA.gov
FDA Decision Cleared SESE
Date Received April 28, 1980
Decision Date May 20, 1980
Days to Decision 22 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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