Arthrex BioSuture

Suture, Nonabsorbable, Synthetic, Polyethylene

Arthrex Inc.

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

Pre-market Notification Details

Device IDK220880
510k NumberK220880
Device Name:Arthrex BioSuture
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactStacy Valdez
CorrespondentStacy Valdez
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 Received2022-03-25
Decision Date2022-10-27

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.