Nuvasive BASE. IBF w/ Screws. Lumbar/T-Lumbar. SCREW. Catalog #6955172

Vendor/Manufacturer: Nuvasive

Product/Product Line: BASE Screw

Vendor/Manufacturer Catalog #: 6955172

Global Unique Device (GUD) Primary Device Identifier Number: 00887517802736

Global Unique Device (GUD) Device Description:

BASE Ti Bolt, 5.0x17.5mm Variable

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Metallic spinal fusion cage, non-sterile

Category 1: Spine

Category 2: Interbody Fusion with Integrated Screws - Lumbar/T-Lumbar

Category 3: Screw

Category 4: Lumbar/T-Lumbar

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: OVD

FDA Classification Product Code Device Name:

Intervertebral Fusion Device With Integrated Fixation, Lumbar

FDA Premarket Submissions: K151214

SUBSTANTIALLY EQUIVALENT to the following products:

1. NuVasive Brigade® Hyperlordotic System

2. NuVasive CoRoent® XLR Standalone System

3. NuVasive CoRoent® Titanium System

4. NuVasive CoRoent® System

5. Surgicraft Limited STALIF® TT Intervertebral Body Fusion System

6. Centinel Spine Midline II / Midline II-Ti