Arthrex SutureTape

Suture, Nonabsorbable, Synthetic, Polyethylene

Arthrex Inc.

The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Suturetape.

Pre-market Notification Details

Device IDK221354
510k NumberK221354
Device Name:Arthrex SutureTape
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactLai Saeteurn
CorrespondentLai Saeteurn
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-05-10
Decision Date2022-09-09

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