R3 XLPE LINERS

Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous

SMITH & NEPHEW, INC.

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

Pre-market Notification Details

• Device ID: K113848
• 510k Number: K113848
• Device Name: R3 XLPE LINERS
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: John Connor
• Correspondent: John Connor; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: MBL
• Subsequent Product Code: JDI
• Subsequent Product Code: LZO
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-12-29
• Decision Date: 2012-04-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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