Arthrex SwiveLock Suture Anchor

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 Suture Anchor.

Pre-market Notification Details

Device IDK193503
510k NumberK193503
Device Name:Arthrex SwiveLock Suture Anchor
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactJessica L. Singelais
CorrespondentJessica L. Singelais
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-12-18
Decision Date2020-01-15

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