ARTHREX BIOWIRE

Suture, Nonabsorbable, Synthetic, Polyester

ARTHREX, INC.

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

Pre-market Notification Details

Device IDK091018
510k NumberK091018
Device Name:ARTHREX BIOWIRE
ClassificationSuture, Nonabsorbable, Synthetic, Polyester
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactSally Foust
CorrespondentSally Foust
ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
Product CodeGAS  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-04-09
Decision Date2010-07-30

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