REDAPT Porous Acetabular Shell

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.

Pre-market Notification Details

Device IDK181366
510k NumberK181366
Device Name:REDAPT Porous Acetabular Shell
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
ContactBryan Cowell
CorrespondentBryan Cowell
Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
Product CodeLPH  
Subsequent Product CodeJDI
Subsequent Product CodeKWY
Subsequent Product CodeKWZ
Subsequent Product CodeLZO
Subsequent Product CodeOQG
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-05-23
Decision Date2018-09-24
Summary:summary

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