Cleared Traditional

Smith & Nephew, Inc. R3? Constrained Liner

K162641 · Smith & Nephew, Inc. · Orthopedic
Jun 2017
Decision
270d
Days
Class 2
Risk

About This 510(k) Submission

K162641 is an FDA 510(k) clearance for the Smith & Nephew, Inc. R3? Constrained Liner, a Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer (Class II — Special Controls, product code KWZ), submitted by Smith & Nephew, Inc. (Memphis, US). The FDA issued a Cleared decision on June 19, 2017, 270 days after receiving the submission on September 22, 2016. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3310.

Submission Details

510(k) Number K162641 FDA.gov
FDA Decision Cleared SESE
Date Received September 22, 2016
Decision Date June 19, 2017
Days to Decision 270 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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