MENISCAL CINCH

Suture, Nonabsorbable, Synthetic, Polyethylene

ARTHREX, INC.

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

Pre-market Notification Details

Device IDK073149
510k NumberK073149
Device Name:MENISCAL CINCH
ClassificationSuture, Nonabsorbable, Synthetic, Polyethylene
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactSally Foust
CorrespondentSally Foust
ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
Product CodeGAT  
CFR Regulation Number878.5000 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2007-11-08
Decision Date2008-02-11
Summary:summary

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