FDA 510(k)

Smith & Nephew, Inc. R3™ Constrained Liner

K-Number: K162641 · 2017-06-19

Decision Date2017-06-19

Product CodeKWZ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Smith & Nephew, Inc. R3™ Constrained Liner 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 2017-06-19 under 510(k) number K162641. 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, Inc. R3™ Constrained Liner?

Smith & Nephew, Inc. R3™ Constrained Liner is a medical device that received FDA 510(k) clearance on 2017-06-19. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K162641.

When did Smith & Nephew, Inc. R3™ Constrained Liner receive FDA 510(k) clearance?

Smith & Nephew, Inc. R3™ Constrained Liner received FDA 510(k) clearance on 2017-06-19, under 510(k) number K162641.

Who is the listed applicant for Smith & Nephew, Inc. R3™ Constrained Liner?

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, Inc. R3™ Constrained Liner?

The FDA product code for Smith & Nephew, Inc. R3™ Constrained Liner is KWZ.

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Other records listing Smith & Nephew, Inc. as applicant

K261968Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one black knotless and one blue MINITAPE suture (72205981); Q-FIX KNOTLESS All-Suture Anchor, 2.8mm, with one blue knotless and one black MINITAPE suture (72205982)K254084AETOS Shoulder System - CONCELOC Glenoids PMA P000057Finger semi-constrained pyrolytic carbon uncemented prosthesis K252416AETOS Shoulder System Meta Humeral Prosthesis Size 0 K252129AETOS Shoulder System Stemless Humeral Prosthesis K251627BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid blue); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR 2.3 PK Suture Anchor w/ ULTRABRAID (#2) Suture (white); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid black); BIORAPTOR CURVED 2.3 PK Suture Anchor w/ ONE 38 ULTRABRAID (#2) Suture (cobraid blue)

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Related Devices (Code: KWZ)

K241461Mpact Constrained LinerMedacta International S.A.K240639PINNACLETM Constrained Acetabular LinersDepuy Ireland UC 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.

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.