MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP 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 Modification To Smith & Nephew Intramedullary Hip Screw.

Pre-market Notification Details

Device IDK040656
510k NumberK040656
Device Name:MODIFICATION TO SMITH & NEPHEW INTRAMEDULLARY HIP SCREW
ClassificationScrew, Fixation, Bone
Applicant SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis,  TN  38116
ContactJanet Akil
CorrespondentJanet Akil
SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis,  TN  38116
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-12
Decision Date2004-05-25
Summary:summary

NIH GUDID Devices

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