POLARSTEM Collared (Standard And Lateral) And Valgus Femoral Stem With Ti/HA

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Polarstem Collared (standard And Lateral) And Valgus Femoral Stem With Ti/ha.

Pre-market Notification Details

Device IDK143739
510k NumberK143739
Device Name:POLARSTEM Collared (Standard And Lateral) And Valgus Femoral Stem With Ti/HA
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant SMITH & NEPHEW, INC. 7135 GOODLETT FARMS PARKWAY Cordova,  TN  38016
ContactJeff Sprague
CorrespondentJeff Sprague
SMITH & NEPHEW, INC. 7135 GOODLETT FARMS PARKWAY Cordova,  TN  38016
Product CodeLZO  
Subsequent Product CodeKWY
Subsequent Product CodeLWJ
Subsequent Product CodeMEH
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-12-30
Decision Date2015-04-20
Summary:summary

NIH GUDID Devices

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