SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW

Screw, Fixation, Bone

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Gts Sleeve And Gts Tapered Screw.

Pre-market Notification Details

Device IDK040542
510k NumberK040542
Device Name:SMITH & NEPHEW GTS SLEEVE AND GTS TAPERED SCREW
ClassificationScrew, Fixation, Bone
Applicant SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover,  MA  01810
ContactMarion W Gordon
CorrespondentMarion W Gordon
SMITH & NEPHEW, INC. 150 MINUTEMAN RD. Andover,  MA  01810
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-02
Decision Date2004-08-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
03596010510976 K040542 000
03596010510969 K040542 000
03596010510952 K040542 000

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