Mecta-C TiPEEK

Intervertebral Fusion Device With Bone Graft, Cervical

Medacta International

The following data is part of a premarket notification filed by Medacta International with the FDA for Mecta-c Tipeek.

Pre-market Notification Details

Device IDK142744
510k NumberK142744
Device Name:Mecta-C TiPEEK
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant Medacta International Strada Regina Castel San Pietro,  CH Ch 6874
ContactAdam Gross
CorrespondentMichael G Loiterman
Medacta USA 1556 W Carroll Ave Chicago,  IL  60607
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-09-24
Decision Date2015-05-07
Summary:summary

NIH GUDID Devices

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