CABLING SYSTEM TROCHANTER HOOK

Cerclage, Fixation

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Cabling System Trochanter Hook.

Pre-market Notification Details

Device IDK043252
510k NumberK043252
Device Name:CABLING SYSTEM TROCHANTER HOOK
ClassificationCerclage, Fixation
Applicant SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis,  TN  38116
ContactJohn Reabe
CorrespondentJohn Reabe
SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis,  TN  38116
Product CodeJDQ  
CFR Regulation Number888.3010 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-11-23
Decision Date2005-01-14
Summary:summary

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