Cleared Traditional

STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM

K875156 · Richards Medical Co., Inc. · Orthopedic
Jan 1988
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K875156 is an FDA 510(k) clearance for the STAINLESS STEEL ORTHOPAEDIC CABLE SYSTEM, a Cerclage, Fixation (Class II — Special Controls, product code JDQ), submitted by Richards Medical Co., Inc. (Memphus, US). The FDA issued a Cleared decision on January 20, 1988, 36 days after receiving the submission on December 15, 1987. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3010.

Submission Details

510(k) Number K875156 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 1987
Decision Date January 20, 1988
Days to Decision 36 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary —

Device Classification

Product Code JDQ — Cerclage, Fixation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3010

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