INTRAFIX(TM) Advance Tibial Fastener System

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 Intrafix(tm) Advance Tibial Fastener System.

Pre-market Notification Details

Device IDK160804
510k NumberK160804
Device Name:INTRAFIX(TM) Advance Tibial Fastener System
ClassificationFastener, Fixation, Biodegradable, Soft Tissue
Applicant MEDOS INTERNATIONAL SARL CHEMIN-BLANC 38, CASE POSTALE Le Locle,  CH Ch 2400
ContactKristine Christo
CorrespondentKristine Christo
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY 325 PARAMOUNT DR. Raynham,  MA  02767
Product CodeMAI  
CFR Regulation Number888.3030 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-03-23
Decision Date2016-07-19
Summary:summary

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