Cleared Traditional

SMITH & NEPHEW R3 CONSTRAINED LINERS

K122139 · Smith & Nephew, Inc. · Orthopedic
Oct 2012
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K122139 is an FDA 510(k) clearance for the SMITH & NEPHEW R3 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 October 16, 2012, 89 days after receiving the submission on July 19, 2012. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3310.

Submission Details

510(k) Number K122139 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2012
Decision Date October 16, 2012
Days to Decision 89 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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