REDAPT Porous Acetabular Shell And Cemented Liner

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 Redapt Porous Acetabular Shell And Cemented Liner.

Pre-market Notification Details

• Device ID: K150790
• 510k Number: K150790
• Device Name: REDAPT Porous Acetabular Shell And Cemented Liner
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: SMITH & NEPHEW, INC. 7135 GOODLETT FARMS PARKWAY Cordova, TN 38016
• Contact: Jeff Sprague
• Correspondent: Jeff Sprague; SMITH & NEPHEW, INC. 7135 GOODLETT FARMS PARKWAY Cordova, TN 38016
• Product Code: LPH
• Subsequent Product Code: JDI
• Subsequent Product Code: KWZ
• Subsequent Product Code: LZO
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2015-03-25
• Decision Date: 2015-11-16
• Summary: summary

NIH GUDID Devices

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