ZimVie ROI-C® Cervical Cage. Catalog #CMC1445P

Vendor/Manufacturer: ZimVie

Product/Product Line: ROI-C® Cervical Cage 

Vendor/Manufacturer Catalog #: CMC1445P

Global Unique Device (GUD) Primary Device Identifier Number: 

03662663023573

Global Unique Device (GUD) Device Description: 

ROI-C LORDOTIC COATED IMPLANT 12x14 H9

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Metal-polymer composite spinal interbody fusion cage

Global Medical Device Nomenclature (GMDN) Definition:

A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of a non-bioabsorbable synthetic polymer with a metallic coating that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

FDA Regulation Medical Specialty: 

Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3080

FDA Regulation Description Classification Name: 

Intervertebral body fusion device

FDA Classification Product Code: OVE

FDA Classification Product Code Device Name: 

Intervertebral fusion device with integrated fixation, cervical

FDA Premarket Submissions: TBD

The ZimVie ROI-C® Cervical Cage is SUBSTANTIALLY EQUIVALENT to the following product(s): 

1. TBD

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