Cleared Traditional

MODULAR COLLARED HJD TOTAL HIP SYSTEM

K884457 · Richards Medical Co., Inc. · Orthopedic
Nov 1988
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K884457 is an FDA 510(k) clearance for the MODULAR COLLARED 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 November 17, 1988, 24 days after receiving the submission on October 24, 1988. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K884457 FDA.gov
FDA Decision Cleared SESE
Date Received October 24, 1988
Decision Date November 17, 1988
Days to Decision 24 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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