Vendor/Manufacturer: Stryker K2M
Product/Product Line: CASCADIA® Lateral 3D Interbody System
Vendor/Manufacturer Catalog #: 6101-2225020L28-G2
Global Unique Device (GUD) Primary Device Identifier Number: 10888857390089
Global Unique Device (GUD) Device Description:
Lateral Interbody, Size 22 x 50 x 20 mm, 28°
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Vertebral body prosthesis
Global Medical Device Nomenclature (GMDN) Definition:
An implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3080
FDA Regulation Description Classification Name:
Hip joint femoral (hemi-hip) trunnion-bearing metal/polyacetal cemented prosthesis
FDA Classification Product Code(s): MAX, ODP, OVD
FDA Classification Product Code Device Name(s):
MAX: Intervertebral fusion device with bone graft, lumbar
ODP: Intervertebral fusion device with bone graft, cervical
OVD: Intervertebral fusion device with integrated fixation, lumbar
The Stryker CASCADIA® Lateral 3D Interbody System is SUBSTANTIALLY EQUIVALENT to the following products:
For more information, please visit us at Infonomics.com
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