REDAPT Anteverted Cemented Liner

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Redapt Anteverted Cemented Liner.

Pre-market Notification Details

• Device ID: K160923
• 510k Number: K160923
• Device Name: REDAPT Anteverted Cemented Liner
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: SMITH & NEPHEW, INC. 7135 GOODLETT FARMS PARKWAY Cordova, TN 38016
• Contact: Kim Phan
• Correspondent: Kim Phan; SMITH & NEPHEW, INC. 7135 GOODLETT FARMS PARKWAY Cordova, TN 38016
• Product Code: JDI
• Subsequent Product Code: KWZ
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-04-04
• Decision Date: 2016-11-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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