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 IDK192441
510k NumberK192441
Device Name:Arthrex SwiveLock Anchors
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -5553
ContactJessica L. Singelais
CorrespondentJessica L. Singelais
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -5553
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-09-06
Decision Date2019-10-17

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