SeaSpine SHORELINE RT™ Anterior Cervical Interbody System. Catalog #85-6107

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May 16, 20241 min read

Vendor/Manufacturer: SeaSpine

Product/Product Line: SHORELINE RT™ Anterior Cervical Interbody System

Vendor/Manufacturer Catalog #: 85-6107

Global Unique Device (GUD) Primary Device Identifier Number:

10889981163815

Global Unique Device (GUD) Device Description:

Interbody, 16x14x7mm, 7 Degree, RT

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Metal-polymer composite 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 a non-bioabsorbable synthetic polymer with a metallic coating 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: ODP, OVE

FDA Classification Product Code Device Name(s):

ODP: Intervertebral fusion device with bone graft, cervical

OVE: Intervertebral fusion device with integrated fixation, cervical

FDA Premarket Submissions: K183083

The SeaSpine SHORELINE RT™ Anterior Cervical Interbody System is SUBSTANTIALLY EQUIVALENT to the following product(s):

1. Globus Medical Patriot Colonial Spacer