Vendor/Manufacturer: Globus Medical
Product/Product Line: SABLE Interbody Fusion Device
Vendor/Manufacturer Catalog #: 1172.2121S
Global Unique Device (GUD) Primary Device Identifier Number:
00889095966046
Global Unique Device (GUD) Device Description:
SABLE Spacer, 10x26, 7-14mm, 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
FDA Premarket Submissions: K192115
SUBSTANTIALLY EQUIVALENT to the following products:
1. RISE® Spacer
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