K2M EVEREST Lumbar Pedicle Screw System. CONNECTOR. Two-Level. Catalog #2901-74050

Vendor/Manufacturer: K2M, Inc.

Product/Product Line: EVEREST Connector

Vendor/Manufacturer Catalog #: 2901-74050

Global Unique Device (GUD) Primary Device Identifier Number: 10888857038509

Global Unique Device (GUD) Device Description:

Transverse Connector, Size Ø5.5/6.0 mm (M)

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Bone-screw internal spinal fixation system, non-sterile

Category 1: Spine

Category 2: Lumbar Pedicle Screw Systems

Category 3: Connector

Category 4: Two Level

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

FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3070

FDA Regulation Description Classification Name:

Pedicle Screw Spinal System

FDA Classification Product Code: NKB

FDA Classification Product Code Device Name:

Thoracolumbosacral Pedicle Screw System

SUBSTANTIALLY EQUIVALENT to the following products:

1. Globus REVERE

2. DePuy EXPEDIUM

3. K2M EVEREST Spinal System