Vendor/Manufacturer: Alphatec Spine
Product/Product Line: Solanas® Posterior Stabilization System
FDA Regulation Medical Specialty: Orthopedic Devices - Prosthetic Devices
FDA Regulation Number: 888.3070
FDA Regulation Description Classification Name:
Pedicle Screw Spinal System
FDA Classification Product Code: NKB
FDA Classification Product Code Device Name:
Thoracolumbosacral Pedicle Screw System
SUBSTANTIALLY EQUIVALENT to the following products:
Device Description:
The Solanas® Posterior Stabilization System is a spinal fixation system intended to improve stability of the occipital, cervical, and thoracic areas of the spine (C1-T3).
Indications for Use:
It is intended that this device, in any system configuration, be removed after the development of solid fusion mass. Hook components are indicated for use at C1-C7. Polyaxial screws are limited to placement in the upper thoracic spine (T1-T3) in treating thoracic conditions only. These screws are not intended for placement in the cervical spine.
The components in the Solanas® Posterior Stabilization System can be linked to the components in the Zodiac Polyaxial Spinal Fixation System offered by Alphatec Spine using the Axial Rod Connectors, Parallel Rod Connectors or Transitional Rods.
• Degenerative Disc Disease (DDD) defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.
• Spondylolisthesis
• Spinal Stenosis
• Fracture/Dislocation
• Atlanto/Axial fracture with instability
• Revision of previous cervical spine surgery
• Tumors
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