ARTHREX SWIVELOCK ANCHORS

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 Swivelock Anchors.

Pre-market Notification Details

Device IDK101823
510k NumberK101823
Device Name:ARTHREX SWIVELOCK ANCHORS
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples,  FL  34108 -1945
ContactSally Foust
CorrespondentSally Foust
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 Received2010-06-30
Decision Date2011-01-07
Summary:summary

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