REDAPT Modular 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 Modular Acetabular Shell.

Pre-market Notification Details

Device IDK182109
510k NumberK182109
Device Name:REDAPT Modular Acetabular Shell
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
ContactMeenakshi Gupta
CorrespondentMeenakshi Gupta
Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-08-03
Decision Date2018-11-16
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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00885556657799 K182109 000

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