ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW

Fastener, Fixation, Biodegradable, Soft Tissue

ARTHREX, INC.

The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Bio-composite Suture Anchors: Arthrex Bio-composite Pushlock, Bio-composite Tak And Bio-composite Corkscrew.

Pre-market Notification Details

Device IDK082810
510k NumberK082810
Device Name:ARTHREX BIO-COMPOSITE SUTURE ANCHORS: ARTHREX BIO-COMPOSITE PUSHLOCK, BIO-COMPOSITE TAK AND BIO-COMPOSITE CORKSCREW
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactNancy Hoft
CorrespondentNancy Hoft
ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-09-24
Decision Date2009-01-23
Summary:summary

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