Altus Spine SILVERSTONE Interbody Fusion System. Catalog #PS-261011

Vendor/Manufacturer: Altus Spine

Product/Product Line: SILVERSTONE Interbody Fusion System

Vendor/Manufacturer Catalog #: PS-261011

Global Unique Device (GUD) Primary Device Identifier Number:

B417PS2610111

Global Unique Device (GUD) Device Description:

PEEK, TLIF, 26L X 10W X 11H

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Polymeric spinal interbody fusion cage

Global Medical Device Nomenclature (GMDN) Definition:

A device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

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(s): MAX, MQP

FDA Classification Product Code Device Name(s):

MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

MQP: Spinal Vertebral Body Replacement Device

FDA Premarket Submission: K182406 , K170553 , K211837 The Altus Spine SILVERSTONE Interbody Fusion System is SUBSTANTIALLY EQUIVALENT to the following product(s): 1. Vertebron Interbody Fusion System

2. Xenco Medical Set-X Hyperlordotic Implant

3. Altus Spine Interbody Fusion System

4. SeaSpine® Vu a˙POD™ Prime NanoMetalele® Interbody Fusion Device

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