Arthrex ACL TightRope®, PCL TightRope®, And TightRope® II

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 Acl Tightrope®, Pcl Tightrope®, And Tightrope® Ii.

Pre-market Notification Details

Device IDK221128
510k NumberK221128
Device Name:Arthrex ACL TightRope®, PCL TightRope®, And TightRope® II
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactLai Saeteurn
CorrespondentLai Saeteurn
Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-04-18
Decision Date2022-10-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.