HEALIX ADVANCE Anchor With PERMATAPE Suture

Fastener, Fixation, Biodegradable, Soft Tissue

Medos International SARL

The following data is part of a premarket notification filed by Medos International Sarl with the FDA for Healix Advance Anchor With Permatape Suture.

Pre-market Notification Details

Device IDK170639
510k NumberK170639
Device Name:HEALIX ADVANCE Anchor With PERMATAPE Suture
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant Medos International SARL Chemin-Blanc 38, Case Postale Le Locle,  CH Ch 2400
ContactJulie Vafides
CorrespondentJulie Vafides
DePuy Mitek, Inc., A Johnson And Johnson Company 325 Paramount Drive Raynham,  MA  02767
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-03-02
Decision Date2017-05-18
Summary:summary

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