Smith & Nephew, Inc. R3™ Constrained Liner

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer

Smith & Nephew, Inc.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew, Inc. R3™ Constrained Liner.

Pre-market Notification Details

• Device ID: K162641
• 510k Number: K162641
• Device Name: Smith & Nephew, Inc. R3™ Constrained Liner
• Classification: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
• Applicant: Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016
• Contact: Natalie P. Williams
• Correspondent: Dongeun Kim; Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016
• Product Code: KWZ
• CFR Regulation Number: 888.3310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-09-22
• Decision Date: 2017-06-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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