Knotless SutureTak Anchors

Fastener, Fixation, Biodegradable, Soft Tissue

Arthrex, Inc.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Knotless Suturetak Anchors.

Pre-market Notification Details

Device IDK180594
510k NumberK180594
Device Name:Knotless SutureTak Anchors
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant Arthrex, Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactIvette Galmez
CorrespondentIvette Galmez
Arthrex, Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-03-06
Decision Date2018-06-22
Summary:summary

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