HEALIX ADVANCE Anchor With DYNATAPE Suture

Fastener, Fixation, Nondegradable, 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 Dynatape Suture.

Pre-market Notification Details

Device IDK200949
510k NumberK200949
Device Name:HEALIX ADVANCE Anchor With DYNATAPE Suture
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Medos International SARL Chemin-Blanc 38, Case Postale Le Locle,  CH Ch 2400
ContactElizabeth Messana
CorrespondentElizabeth Messana
DePuy Synthes Mitek, A Johnson And Johnson Company 325 Paramount Drive Raynham,  MA  02767
Product CodeMBI  
CFR Regulation Number888.3040 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-04-09
Decision Date2020-06-04

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