(112 days)
The PreView™ Anterior Ccrvical Plate System is intended for the treatment of the cervical spine in skeletally mature patients.receiving fusion-by autogenous and/or allogenic bone graft. The implants are attached to the anterior cervical spine (C2-T1) with removal of the implants after the attainment of a solid fusion mass. The PreView™ Anterior Cervical Plate System is intended for use under the following indications: )
· Degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies)
• Spondylolisthesis
- · Trauma (i.e., fracture or dislocation)
· Spinal stenosis - · Deformitics or curvatures (i.e., scoliosis, kyphosis, and/or lordosis)
• Tumor - Pseudoarthrosis
- · Failed previous fusion
Not Found
This document is a 510(k) clearance letter from the FDA for a medical device called the "PreView™ Anterior Cervical Plate System." It confirms that the device is substantially equivalent to legally marketed predicate devices.
The document does not contain information regarding acceptance criteria or a study proving that the device meets acceptance criteria.
Instead, it pertains to the regulatory clearance process, specifically detailing:
- Device Name: PreView™ Anterior Cervical Plate System
- Applicant: Alphaspine, Incorporated
- FDA Decision Date: December 4, 2006
- Regulation Number and Name: 21 CFR 888.3060, Spinal intervertebral body fixation orthosis
- Regulatory Class: II
- Product Code: KWO
- Indications for Use: Treatment of the cervical spine (C2-T1) in skeletally mature patients receiving fusion by autogenous and/or allogenic bone graft, with removal of implants after solid fusion. Specific indications include Degenerative disc disease (DDD), Spondylolisthesis, Trauma (fracture or dislocation), Spinal stenosis, Deformities or curvatures (scoliosis, kyphosis, lordosis), Tumor, Pseudoarthrosis, and Failed previous fusion.
Therefore, I cannot provide the requested information about acceptance criteria and study details based on the provided text. This document is a regulatory approval, not a scientific study report.
§ 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.