DePuy Synthes ZERO-P VA. IBF w/ Screws, Cervical. SCREW. Catalog #04.647.836

Vendor/Manufacturer: DePuy Synthes

Product/Product Line: ZERO-P VA Screw

Vendor/Manufacturer Catalog #: 04.647.836

Global Unique Device (GUD) Primary Device Identifier Number:

10705034751368

Global Unique Device (GUD) Device Description:

3.7MM TI CERVICAL SPINE SCREW SLF-DRLG/VARIABLE ANGLE 16MM

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Bone-screw internal spinal fixation system, non-sterile

Category 1: Spine

Category 2: Interbody Fusion with Integrated Screws - Cervical

Category 3: Screw

Category 4: Cervical

Quantity of "Each"es needed in each System/Set: 2

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: K112068

SUBSTANTIALLY EQUIVALENT to the following products:

1. Synthes Zero-P device

2. Sulzer BAKTM/Cervical IBE

3. Synthes Vectra

4. Synthes Vectra-T

5. Globus Coalition

6. Medtronic PEEK Prevail

7. RSB InterPlate C-P