SpineArt ROMEO. Lumbar Pedicle Screw System. SET SCREW. Two-Level. Catalog #ELL-SC 01 00-S

Vendor/Manufacturer: SpineArt

Product/Product Line: ROMEO Set Screw

Vendor/Manufacturer Catalog #: ELL-SC 01 00-S

Global Unique Device (GUD) Primary Device Identifier Number: 07640151093839

Global Unique Device (GUD) Device Description:

Hexalobe Setscrew

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Bone-screw internal spinal fixation system, sterile

Category 1: Spine

Category 2: Lumbar Pedicle Screw Systems

Category 3: Set Screw

Category 4: Two Level

Quantity of "Each"es needed in each System/Set: 6

FDA Regulation Medical Specialty:

Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3070

FDA Regulation Description Classification Name:

Thoracolumbosacral pedicle screw system

FDA Classification Product Code: NKB

FDA Classification Product Code Device Name:

Thoracolumbosacral Pedicle Screw System

FDA Premarket Submissions: K141835, K172101

SUBSTANTIALLY EQUIVALENT to the following products:

1. TSRH spinal system by Medtronic Sofamor Danek, Inc.

2. CD horizon X10 Crosslink Plates by Medtronic Sofamor Danek, Inc.

3. Reform Pedicle Screw System manufactured by Precision Spine, Inc.

4. Xia manufactured by Stryker Spine

5. Xia - Mantis manufactured by Stryker Spine