Arthrex Knotless Mini TightRopes

Washer, Bolt Nut

Arthrex Inc.

The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Knotless Mini Tightropes.

Pre-market Notification Details

Device IDK213644
510k NumberK213644
Device Name:Arthrex Knotless Mini TightRopes
ClassificationWasher, Bolt Nut
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactRebecca R Homan
CorrespondentRebecca R Homan
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -5553
Product CodeHTN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-11-18
Decision Date2021-12-17

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