Vendor/Manufacturer: Nuvasive
Product/Product Line: TLX Interbody Fusion Device
Vendor/Manufacturer Catalog #: 5902026P2
Global Unique Device (GUD) Primary Device Identifier Number:
00887517958129
Global Unique Device (GUD) Device Description:
TLX20, 10x11x26mm 20°
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: K171633
SUBSTANTIALLY EQUIVALENT to the following products: