MILAGRO ADVANCE PEEK Interference Screw

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 Milagro Advance Peek Interference Screw.

Pre-market Notification Details

Device IDK161001
510k NumberK161001
Device Name:MILAGRO ADVANCE PEEK Interference Screw
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant MEDOS INTERNATIONAL SARL CHEMIN-BLANC 38, CASE POSTALE Le Locle,  CH Ch 2400
ContactKristine Christo
CorrespondentKristine Christo
DEPUY MITEK INC., 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 Received2016-04-11
Decision Date2016-06-09
Summary:summary

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