Globus Medical RISE-L. Interbody Fusion Device. Lumbar/T-Lumbar. Non-Bone. Cat #193.503

Vendor/Manufacturer: Globus Medical

Product/Product Line: RISE-L Interbody Fusion Device

Vendor/Manufacturer Catalog #: 193.503

Global Unique Device (GUD) Primary Device Identifier Number:

00889095308129

Global Unique Device (GUD) Device Description:

RISE-L Spacer 18 x 45mm, 7-14mm, 3-15°

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: K113447

SUBSTANTIALLY EQUIVALENT to the following products:

1. Globus Medical CALIBER Spacer