Xtant Medical IRIX-C. IBF w/ Screws, Cervical. IMPLANT. Catalog #X066-161308L-PC

Vendor/Manufacturer: Xtant Medical

Product/Product Line: IRIX-C Implant

Vendor/Manufacturer Catalog #: X066-161308L-PC

Global Unique Device (GUD) Primary Device Identifier Number:

M697X066161308LPC1

Global Unique Device (GUD) Device Description:

IRIX-C INTEGRATED SPACER ASSY, 16 X 13 X 7°, 8mm, PC

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Polymeric spinal interbody fusion cage

Category 1: Spine

Category 2: Interbody Fusion with Integrated Screws - Cervical

Category 3: Implant

Category 4: Cervical

Quantity of "Each"es needed in each System/Set: 1

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: OVE

FDA Classification Product Code Device Name:

Intervertebral Fusion Device With Integrated Fixation, Cervical

FDA Premarket Submissions: K162944

SUBSTANTIALLY EQUIVALENT to the following products:

1. Orthofix, Inc.: Cervical Stand Alone System

2. Globus Medical: COALITION Spacer

3. Spinal Elements: Vertu/Vertu TI Bond

4. Pioneer Surgical Unison (RTI Surgical)

5. Choice Spine: TomCat

6. LDR Spine: ROI‐C

7. Centinel Spine: STALIF C/STALIF C‐Ti