Arthrex SoftStitch

Suture, Nonabsorbable, Synthetic, Polyethylene

Arthrex Inc.

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

Pre-market Notification Details

Device IDK190707
510k NumberK190707
Device Name:Arthrex SoftStitch
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactDavid L Rogers
CorrespondentDavid L Rogers
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-03-19
Decision Date2020-10-02

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