Vendor/Manufacturer: Globus Medical, Inc.
Product/Product Line: RELIEVE Laminoplasty Fixation System
Vendor/Manufacturer Catalog #: 336.113
Global Unique Device (GUD) Primary Device Identifier Number:
00889095215311
Global Unique Device (GUD) Device Description:
RELIEVE Radiolucent Plate, Open Door, 13mm
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Spinal fixation plate, non-bioabsorbable
Global Medical Device Nomenclature (GMDN) Definition:
A small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).
FDA Regulation Medical Specialty:
Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3050
FDA Regulation Description Classification Name:
Spinal interlaminal fixation orthosis
FDA Classification Product Code: NQW
FDA Classification Product Code Device Name:
Orthosis, Spine, Plate, Laminoplasty, Metal
FDA Premarket Submissions: K080664
The Globus Medical RELIEVE Laminoplasty Fixation System is SUBSTANTIALLY EQUIVALENT to the following product(s):
For more information, please visit us at Infonomics.com
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