Icotec Cervical Cage

Intervertebral Fusion Device With Bone Graft, Cervical

Icotec Ag

The following data is part of a premarket notification filed by Icotec Ag with the FDA for Icotec Cervical Cage.

Pre-market Notification Details

Device IDK192897
510k NumberK192897
Device Name:Icotec Cervical Cage
ClassificationIntervertebral Fusion Device With Bone Graft, Cervical
Applicant icotec Ag Industriestrasse 12 9450 Altstaetten(sg),  CH
ContactMarina Hess
CorrespondentJustin Eggleton
MCRA, LLC 1050 K Street NW Suite 1000 Washington,  DC  20001
Product CodeODP  
CFR Regulation Number888.3080 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyOrthopedic
510k Review PanelOrthopedic
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-10-11
Decision Date2020-03-20

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