FDA 510(k)

SMITH & NEPHEW R3 CONSTRAINED LINERS

K-Number: K122139 · 2012-10-16

Decision Date2012-10-16

Product CodeKWZ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SMITH & NEPHEW R3 CONSTRAINED LINERS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2012-10-16 under 510(k) number K122139. The device is classified under product code KWZ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMITH & NEPHEW R3 CONSTRAINED LINERS?

SMITH & NEPHEW R3 CONSTRAINED LINERS is a medical device that received FDA 510(k) clearance on 2012-10-16. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K122139.

When did SMITH & NEPHEW R3 CONSTRAINED LINERS receive FDA 510(k) clearance?

SMITH & NEPHEW R3 CONSTRAINED LINERS received FDA 510(k) clearance on 2012-10-16, under 510(k) number K122139.

Who is the listed applicant for SMITH & NEPHEW R3 CONSTRAINED LINERS?

The FDA 510(k) record lists Smith & Nephew, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMITH & NEPHEW R3 CONSTRAINED LINERS?

The FDA product code for SMITH & NEPHEW R3 CONSTRAINED LINERS is KWZ.

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Other records listing Smith & Nephew, Inc. as applicant

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Related Devices (Code: KWZ)

K241461Mpact Constrained LinerMedacta International S.A.K240639PINNACLETM Constrained Acetabular LinersDepuy Ireland UC K162641Smith & Nephew, Inc. R3™ Constrained LinerSmith & Nephew, Inc.K163497EXPRT™ Revision Hip System - EXPRT™ Hip Distal Stem, EXPRT™ Hip Standard Offset Proximal Body Implant, EXPRT™ Hip Lateral Offset Proximal Body Implant, EXPRT™ Hip Capture BoltEncore Medical L.P.K161610EXPRT Revision Hip SystemEncore Medical L.P.K111635SMITH & NEPHEW RJ CONSTRAINED LINERSSmith & Nephew, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.