Arthrex Mini Hip PushLock

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 Mini Hip Pushlock.

Pre-market Notification Details

Device IDK201786
510k NumberK201786
Device Name:Arthrex Mini Hip PushLock
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactKelsey Roberts
CorrespondentKelsey Roberts
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 Received2020-06-30
Decision Date2020-07-30

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