TRUESPAN Meniscal Repair System

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 Truespan Meniscal Repair System.

Pre-market Notification Details

Device IDK153667
510k NumberK153667
Device Name:TRUESPAN Meniscal Repair System
ClassificationFastener, Fixation, Nondegradable, Soft Tissue
Applicant Medos International SARL Chemin-Blanc 38 Le Locle Neuchatel,  CH 2400
ContactKristine Christo
CorrespondentYayoi Fujimaki
Depuy 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 Received2015-12-21
Decision Date2016-03-24
Summary:summary

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