ARTHREX FIBERTAK SUTURE ANCHOR

Fastener, Fixation, Nondegradable, Soft Tissue

ARTHREX, INC.

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

Pre-market Notification Details

Device IDK140476
510k NumberK140476
Device Name:ARTHREX FIBERTAK SUTURE ANCHOR
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactCourtney Smith
CorrespondentCourtney Smith
ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-26
Decision Date2014-08-13
Summary:summary

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