Arthrex Syndesmosis TightRope XP Buttress Plate Implant System

Washer, Bolt Nut

Arthrex Inc.

The following data is part of a premarket notification filed by Arthrex Inc. with the FDA for Arthrex Syndesmosis Tightrope Xp Buttress Plate Implant System.

Pre-market Notification Details

Device IDK201522
510k NumberK201522
Device Name:Arthrex Syndesmosis TightRope XP Buttress Plate Implant System
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 -1945
Product CodeHTN  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-06-08
Decision Date2020-09-03

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