Arthrex Nano SwiveLock Suture Anchor

Screw, Fixation, Bone

Arthrex Inc.

The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Nano Swivelock Suture Anchor.

Pre-market Notification Details

Device IDK191651
501k NumberK191651
Device Name:Arthrex Nano SwiveLock Suture Anchor
ClassificationScrew, Fixation, Bone
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactRebecca R. Homan
CorrespondentRebecca R. Homan
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeHWC  
Subsequent Product CodeMAI
Subsequent Product CodeMBI
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
501k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-06-20
Decision Date2019-11-06

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