R3 Anteverted 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 Anteverted Liners.

Pre-market Notification Details

• Device ID: K182535
• 510k Number: K182535
• Device Name: R3 Anteverted Liners
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous
• Applicant: Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016
• Contact: Meenakshi Gupta
• Correspondent: Meenakshi Gupta; Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova, TN 38016
• Product Code: MBL
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-09-14
• Decision Date: 2018-11-19
• Summary: summary

NIH GUDID Devices

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