HEALIX ADVANCE Anchor With DYNACORD 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 Dynacord Suture.

Pre-market Notification Details

Device IDK183506
510k NumberK183506
Device Name:HEALIX ADVANCE Anchor With DYNACORD Suture
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant Medos International SARL Chemin-Blanc 38, Case Postale Le Locle,  CH Ch 2400
ContactTatyana Korsunsky
CorrespondentTatyana Korsunsky
DePuy Mitek, 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 Received2018-12-18
Decision Date2019-02-14
Summary:summary

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