ARTHREX FIBERWIRE IN USP SIZES

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 In Usp Sizes.

Pre-market Notification Details

Device IDK021434
510k NumberK021434
Device Name:ARTHREX FIBERWIRE IN USP SIZES
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples,  FL  34104
ContactAnn Waterhouse
CorrespondentAnn Waterhouse
ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples,  FL  34104
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-06
Decision Date2002-11-07
Summary:summary

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