Arthrex TightRope II

Fastener, Fixation, Nondegradable, Soft Tissue

Arthrex Inc.

The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Tightrope Ii.

Pre-market Notification Details

Device IDK202581
510k NumberK202581
Device Name:Arthrex TightRope II
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactKelsey N. Roberts
CorrespondentKelsey N. Roberts
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-08
Decision Date2020-11-04

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