ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY

Screw, Fixation, Bone

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Corkscrew Suture Anchor, Tak, And Pushlock Family.

Pre-market Notification Details

Device IDK061863
510k NumberK061863
Device Name:ARTHREX CORKSCREW SUTURE ANCHOR, TAK, AND PUSHLOCK FAMILY
ClassificationScrew, Fixation, Bone
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactAnn Waterhouse
CorrespondentAnn Waterhouse
ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
Product CodeHWC  
Subsequent Product CodeJDR
Subsequent Product CodeMAI
Subsequent Product CodeMBI
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-06-30
Decision Date2006-10-19
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.