Huvexel FORTIS Anterior Cervical Plate System
- CataBlog
- Dec 31, 2017
- 2 min read
Updated: Jan 1, 2018
Vendor/Manufacturer: Huvexel
Product/Product Line: FORTIS Anterior Cervical Plate System
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3060
FDA Regulation Description Classification Name:
Spinal Intervertebral Body Fixation Orthosis
FDA Classification Product Code: KWQ
FDA Classification Product Code Device Name:
Appliance, Fixation, Spinal Intervertebral Body
SUBSTANTIALLY EQUIVALENT to the following products:
Device Description:
The FORTIS Anterior Cervical Plate System consists of a variety of shapes and sizes of Main Plates, screw, lock-plate and the associated instruments. The lock-plate is pre-assembled to the main plate and designed to prevent screws from backing out. Each component is subjected to a color anodizing process to differentiate the screw type and diameter and to make the surgical process easy.
The plates range in length to accommodate one, two, three, and four level procedures. Main plate is available from 10mm to 112mm. Screws are available in lengths from 10mm to 20mm in 2mm increments. The screws have either a 4.0mm or 4.5mm diameter. They are fixed self-tapping, variable self-tapping screw, fixed self-drilling screw, variable self-drilling. The FORTIS Anterior Cervical Plate System components are supplied non-sterile, are single use and are fabricated from titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136.
Intended Use:
The FORTIS Anterior Cervical Plate System is intended for anterior fixation to the cervical spine C2-C7. The specific clinical indications include: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
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