Precision Spine DAKOTA ACDF Anterior Cervical Discectomy and Fusion System. Catalog #71-AL-4212

CataBlog
Jun 8, 2022
1 min read

Vendor/Manufacturer: Precision Spine

Product/Product Line: DAKOTA ACDF (Anterior Cervical Discectomy and Fusion) System

Vendor/Manufacturer Catalog #: 71-AL-4212

Global Unique Device (GUD) Primary Device Identifier Number: 00840019940726

Global Unique Device (GUD) Device Description:

14 x 12 x 12mm 7° Interbody

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: ODP

FDA Classification Product Code Device Name:

Intervertebral Fusion Device With Bone Graft, Cervical

FDA Classification Product Code: OVE

FDA Classification Product Code Device Name:

Intervertebral Fusion Device With Integrated Fixation, Cervical

FDA Premarket Submission: K203129

The Precision Spine DAKOTA ACDF (Anterior Cervical Discectomy and Fusion) System is SUBSTANTIALLY EQUIVALENT to the following products: