Cleared Traditional

RESUBMITTING OF HJD TOTAL HIP SYSTEM

K881117 · Richards Medical Co., Inc. · Orthopedic
Apr 1988
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K881117 is an FDA 510(k) clearance for the RESUBMITTING OF HJD TOTAL HIP SYSTEM, a Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented (Class II — Special Controls, product code JDI), submitted by Richards Medical Co., Inc. (Memphus, US). The FDA issued a Cleared decision on April 29, 1988, 51 days after receiving the submission on March 9, 1988. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K881117 FDA.gov
FDA Decision Cleared SESE
Date Received March 09, 1988
Decision Date April 29, 1988
Days to Decision 51 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code JDI — Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3350

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