(26 days)
The CODMAN SLIM-LOC™ System is a permanent implant, generally indicated for short-term stabilization of the cervical spine from C2 to C7 employing screw fixation at the anterior face of the vertebral bodies. This product may be employed as an internal fixation device during the time interval required for arthrodesis.
Specific clinical indications for anterior plating include:
Instability caused by trauma;
Instability associated with correction of cervical lordosis and kyphosis deformity;
Instability associated with pseudoarthrosis as a result of previously failed cervical spine surgery;
Instability associated with major reconstructive surgery for primary tumors or metastatic malignant tumors of the cervical spine;
Instability associated with single or multiple level corpectomy in advanced degenerative disk disease, spinal canal stenosis, and cervical myelopathy.
The CODMAN SLIM-LOC™ System consists of an assortment of implantable titanium alloy plates and screws. The plates have an integrated screw locking mechanism to prevent screw back out. A variety of cancellous screw types are provided for surgical convenience.
The provided text describes a 510(k) submission for the CODMAN® SLIM-LOC™ System, a spinal intervertebral body fixation orthosis. However, it does not contain the specific information requested about acceptance criteria and the study that proves the device meets those criteria.
The document states: "This submission relied upon appropriate biomechanical testing necessary to support the device for its intended use." This indicates that biomechanical testing was performed, but it does not specify the acceptance criteria, the results, or details about the study design that would allow completion of the requested table and information.
Therefore, I cannot provide the detailed information requested in questions 1 through 9 based on the provided input. The document is primarily a 510(k) summary and the FDA's response letter indicating substantial equivalence, not a detailed report of the device's 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.