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 IDK203268
510k NumberK203268
Device Name:Arthrex FiberTak Suture Anchor
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactJessica L Singelais
CorrespondentJessica L Singelais
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-05
Decision Date2020-11-27

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