SeaSpine SHORELINE ACS™ Anterior Cervical Interbody System. Catalog #85-3214

Vendor/Manufacturer: SeaSpine

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

Vendor/Manufacturer Catalog #: 85-3214

Global Unique Device (GUD) Primary Device Identifier Number: 

10889981125257

Global Unique Device (GUD) Device Description: 

3.5mm Variable Screw, Self Drilling, 14mm

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Vertebral body prosthesis, non-sterile

Global Medical Device Nomenclature (GMDN) Definition:

A non-sterile implantable device designed to replace or repair (fuse) the spinal bony segments, or vertebrae, lost or injured as a consequence of, e.g., trauma, deformity, tumour, or degenerative disease. It is typically intended to be used with supplemental spinal fixation and may be used with a bone graft. It is usually made of metal, polymer, or a combination of these materials. This device must be sterilized prior to use.

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: OVE

FDA Classification Product Code Device Name(s): 

OVE: Intervertebral fusion device with integrated fixation, cervical

FDA Premarket Submissions: K161081

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

1. Globus Medical Coalition

2. Centinel Spine Stalif c 

3. Centinel Spine Stalif c-ti

4. SeaSpine Zuma-C

5. SeaSpine Cambria NanoMetalene

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