Arthrex FastThread Interference Screw

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 Fastthread Interference Screw.

Pre-market Notification Details

Device IDK180662
510k NumberK180662
Device Name:Arthrex FastThread Interference Screw
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactJessica L. Singelais
CorrespondentJessica L. Singelais
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 Received2018-03-14
Decision Date2018-05-22
Summary:summary

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