ARTHREX FIBERWIRE

Suture, Nonabsorbable, Synthetic, Polyethylene

ARTHREX, INC.

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

Pre-market Notification Details

Device IDK071622
510k NumberK071622
Device Name:ARTHREX FIBERWIRE
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactAnn Waterhouse
CorrespondentAnn Waterhouse
ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-06-14
Decision Date2007-07-03
Summary:summary

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