Vendor/Manufacturer: Globus Medical
Product/Product Line: COLONIAL Interbody Fusion Device
Vendor/Manufacturer Catalog #: 365.707CS
Global Unique Device (GUD) Primary Device Identifier Number:
00889095238044
Global Unique Device (GUD) Device Description:
COLONIAL ACDF TPS Spacer, 14x16, 7°, 7mm
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: ODP
FDA Classification Product Code Device Name:
Intervertebral Fusion Device With Bone Graft, Cervical
Category 1: Spine
Category 2: Interbody Fusion Devices
Category 3: Cervical
Category 4: Non-Bone
FDA Premarket Submissions: K143578
SUBSTANTIALLY EQUIVALENT to the following product(s):
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