Globus Medical RISE. Interbody Fusion Device. Lumbar/T-Lumbar. Non-Bone. Catalog #193.242

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

FDA Premarket Submissions: K113447 , K171848

SUBSTANTIALLY EQUIVALENT to the following products:

1. FORTIFY® Corpectomy Spacers

2. XPand® Corpectomy Spacers

3. NIKO® Corpectomy Spacers

4. SUSTAIN® Spacers

5. COALITION® Spacers

6. PATRIOT® Spacers (Lumbar)

7. PATRIOT® Spacers (Cervical)

8. ALTERA® Spacers

9. CALIBER® Spacers

10. ELSA™ Spacers

11. LATIS® Spacers

12. MONUMENT® Spacers

13. InterContinental® Plate-Spacer

14. MAGNIFY™ Spacers

15. INDEPENDENCE® Spacers

16. TPS Spacers

17. Globus Medical CALIBER TM Spacer