Smith & Nephew, Inc. REDAPT Augments

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

Smith & Nephew, Inc.

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

Pre-market Notification Details

• Device ID: K171073
• 510k Number: K171073
• Device Name: Smith & Nephew, Inc. REDAPT Augments
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• 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: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-04-11
• Decision Date: 2017-11-21
• Summary: summary

NIH GUDID Devices

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