Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem

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. Anthology™ Afit Hip Stem.

Pre-market Notification Details

Device IDK172684
510k NumberK172684
Device Name:Smith & Nephew, Inc. ANTHOLOGY™ AFIT Hip Stem
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova,  TN  38016
ContactJonathan Dimotta
CorrespondentJonathan Dimotta
Smith & Nephew, Inc. 1450 East Brooks Road Memphis,  TN  38116
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-09-06
Decision Date2017-10-03
Summary:summary

NIH GUDID Devices

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