MODIFICATION TO: ARTHREX V-TAK

Screw, Fixation, Bone

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Modification To: Arthrex V-tak.

Pre-market Notification Details

Device IDK050634
510k NumberK050634
Device Name:MODIFICATION TO: ARTHREX V-TAK
ClassificationScrew, Fixation, Bone
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactAnn Waterhouse, Rac
CorrespondentAnn Waterhouse, Rac
ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
Product CodeHWC  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-09
Decision Date2005-03-21
Summary:summary

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