Vendor/Manufacturer: ZimVie
Product/Product Line: ROI-C® Cervical Cage
Vendor/Manufacturer Catalog #: MC1005T
Global Unique Device (GUD) Primary Device Identifier Number:
03662663016971
Global Unique Device (GUD) Device Description:
ROI-C ANCHORING PLATE
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Polymeric spinal fusion cage, sterile
Global Medical Device Nomenclature (GMDN) Definition:
A sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Fixation screws and disposable 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: MQP, ODP
FDA Classification Product Code Device Name(s):
MQP: Spinal Vertebral Body Replacement Device
ODP: Intervertebral Fusion Device With Bone Graft, Cervical
FDA Premarket Submissions: TBD
The ZimVie ROI-C® Cervical Cage is SUBSTANTIALLY EQUIVALENT to the following product(s):
1. TBD
For more information, please visit us at Infonomics.com
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