Cleared Traditional

HJD CALCAR REPLACEMENT PROSTHESIS

K881769 · Richards Medical Co., Inc. · Orthopedic
Jun 1988
Decision
65d
Days
Class 2
Risk

About This 510(k) Submission

K881769 is an FDA 510(k) clearance for the HJD CALCAR REPLACEMENT PROSTHESIS, 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 June 22, 1988, 65 days after receiving the submission on April 18, 1988. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3350.

Submission Details

510(k) Number K881769 FDA.gov
FDA Decision Cleared SESE
Date Received April 18, 1988
Decision Date June 22, 1988
Days to Decision 65 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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