ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR

Screw, Fixation, Bone

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Bio-corkscrew Ft Suture Anchor.

Pre-market Notification Details

Device IDK043337
510k NumberK043337
Device Name:ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR
ClassificationScrew, Fixation, Bone
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactSally Foust
CorrespondentSally Foust
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 Received2004-12-03
Decision Date2004-12-14
Summary:summary

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