(76 days)
The CD HORIZON™ Anterior Spinal System is designed to aid in the surgical correction and stabilization of the system is intended to assist stabilization until a solid spinal fusion develops. The specific indications for the CD HORIZON™ Anterior Spinal System are the following:
- Degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies).
- Pseudoarthrosis
- Stenosis
- Spondylolisthesis
- Spinal deformities: scoliosis, kyphosis, lordosis
- Fracture
- Unsuccessful previous attempts at spinal fusion
- Tumor resection
All components of the CD HORIZON" Anterior Spinal System are intended to be fixed/attached to the anterolateral spine by screws/staples in the thoracic and/or lumbar areas only.
The CD HORIZON™ Anterior Spinal System consists of rods, screws, a set screw, and staples. In general, the system features implant components which can be used with either 5.5mm and 6.35mm Sofamor Danek rods. The 5.5mm GDLH", 6.35mm TSRH®, and 6.35mm LIBERTY" rods can be used with the CD HORIZON™ Anterior Spinal System. Instrumentation is also available to facilitate implantation of the device components. The purpose of the CD HORIZON" Anterior Spinal System is to provide stabilization during the development of a solid spinal fusion. The CD HORIZON" Anterior Spinal System implant components are fabricated from ASTM F138 (or its ISO equivalent) stainless steel and may be sold sterile or non-sterile. Stainless steel implants are not to be used with titanium alloy implant components in a spinal construct
This 510(k) summary for the CD HORIZON™ Anterior Spinal System does not contain the information requested in your bullet points regarding acceptance criteria and a study proving the device meets those criteria.
Instead, this document focuses on:
- Device Identification: Company, proprietary name, classification name.
- Device Description: Components (rods, screws, set screw, staples), materials (ASTM F138 stainless steel).
- Intended Use/Indications for Use: What the device is designed to do (provide stabilization during fusion) and the specific conditions it treats (degenerative disc disease, pseudoarthrosis, stenosis, etc.).
- Substantial Equivalence: A statement that the device was deemed substantially equivalent to other commercially available devices.
The only mention of "test data" is: "Mechanical test data were supplied in support of the CD HORIZON™ Anterior Spinal System V." However, it does not provide any details about:
- What those tests were.
- The specific acceptance criteria for those tests.
- The actual results of those tests.
- Any sample sizes, ground truth, expert involvement, or statistical methods.
Therefore, I cannot provide the requested table or describe a study proving the device meets acceptance criteria based on the provided text. The document is a regulatory summary, not a detailed technical report of performance testing.
§ 888.3060 Spinal intervertebral body fixation orthosis.
(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.