Vendor/Manufacturer: Orthofix
Product/Product Line: CONSTRUX® Mini PEEK Spacer System
Vendor/Manufacturer Catalog #: 47-4106C
Global Unique Device (GUD) Primary Device Identifier Number: 18257200013302
Global Unique Device (GUD) Device Description:
15mm W x 12mm D x 6mm H, Parallel Implant
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Vertebral body prosthesis, non-sterile
Global Medical Device Nomenclature (GMDN) Definition:
A non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use.
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(s): MQP, ODP
FDA Classification Product Code Device Name(s):
MQP: Spinal Vertebral Body Replacement Device
ODP: Intervertebral Fusion Device With Bone Graft, Cervical
The Orthofix CONSTRUX® Mini PEEK Spacer System is SUBSTANTIALLY EQUIVALENT to the following product(s):
For more information, please visit us at Infonomics.com
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