Spinal Elements CRYSTAL TI-BOND. Interbody Fusion Device. Cervical. Non-Bone. Catalog #P21411-007

Vendor/Manufacturer: Spinal Elements

Product/Product Line: CRYSTAL TI-BOND Interbody Fusion Device

Vendor/Manufacturer Catalog #: P21411-007

Global Unique Device (GUD) Primary Device Identifier Number:

00840606112192

Global Unique Device (GUD) Device Description:

14mm X 11mm 7mm Cage, PC

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Metal-polymer composite 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: K153352

SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Centinel Spine's STALIF C

2. Centinel Spine's STALIF C-Ti

3. Spinal Element's Vertu Cervical Interbody System

4. Spinal Element's Vertu Ti-Bond Cervical Interbody System

5. Spinal Element's Crystal Cervical Interbody System

6. Spinal Element's Crystal Ti-Bond Cervical Interbody System

7. Valeo Spacer System-C Interbody Fusion Device System

8. Valeo-II Interbody Fusion Device System

9. Anatomic PEEK Cervical Fusion System