Arthrex Self Punching SwiveLock Suture 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 Self Punching Swivelock Suture Anchors.

Pre-market Notification Details

Device IDK222263
510k NumberK222263
Device Name:Arthrex Self Punching SwiveLock Suture Anchors
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108
ContactTiffany Mentzel
CorrespondentTiffany Mentzel
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-07-28
Decision Date2022-08-26

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