Vendor/Manufacturer: Globus Medical
Product/Product Line: RISE Interbody Fusion Device
Vendor/Manufacturer Catalog #: 193.242
Global Unique Device (GUD) Primary Device Identifier Number:
00889095213690
Global Unique Device (GUD) Device Description:
RISE Spacer 12x26mm, 10-17mm, 15°
Global Medical Device Nomenclature (GMDN) Preferred Term Name:
Metallic spinal interbody fusion cage
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: MAX
FDA Classification Product Code Device Name:
Intervertebral Fusion Device With Bone Graft, Lumbar
Category 1: Spine
Category 2: Interbody Fusion Devices
Category 3: Lumbar/T-Lumbar
Category 4: Non-Bone
SUBSTANTIALLY EQUIVALENT to the following products:
10. ELSA™ Spacers
11. LATIS® Spacers
14. MAGNIFY™ Spacers
16. TPS Spacers
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