Arthrex 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 Pushlock.

Pre-market Notification Details

Device IDK173240
510k NumberK173240
Device Name:Arthrex PushLock
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant Arthrex Inc. 1370 Creekside Boulevard Naples,  FL  34108 -1945
ContactDavid L. Rogers
CorrespondentDavid L. Rogers
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 Received2017-10-05
Decision Date2018-01-16
Summary:summary

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