Cleared Traditional

SMITH & NEPHEW RJ CONSTRAINED LINERS

K111635 · Smith & Nephew, Inc. · Orthopedic
Sep 2011
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K111635 is an FDA 510(k) clearance for the SMITH & NEPHEW RJ CONSTRAINED LINERS, a Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (Class II — Special Controls, product code KWZ), submitted by Smith & Nephew, Inc. (Memphus, US). The FDA issued a Cleared decision on September 9, 2011, 88 days after receiving the submission on June 13, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3310.

Submission Details

510(k) Number K111635 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2011
Decision Date September 09, 2011
Days to Decision 88 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF

Device Classification

Product Code KWZ — Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3310

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