(77 days)
The InterPlate™ VBR device is indicated for the replacement of a complete or partial vertebrectomy, when used with a bone graft to facilitate fusion. It is designed to restore biomechanical integrity of the thoracic and lumbar spine, from T1 to L5, which has been damaged due to a collapsed or unstable vertebral body resulting from a tumor or traumatic injury.
The InterPlate™ VBR consists of plates, bone screws and screw covers. Various plate sizes are available to accommodate individual patient anatomy and graft material size. Screw covers are individually matched to the plate size.
The provided text does not contain information about specific acceptance criteria or a study that proves the device meets those criteria. Instead, it is a 510(k) summary and FDA clearance letter for the InterPlate™ VBR System, focusing on demonstrating substantial equivalence to previously cleared devices rather than providing specific performance study results.
Therefore, I cannot populate the table or answer the questions as the required information is not present in the given text.
The document primarily states: "Documentation was provided which demonstrated the InterPlate™ VBR System to be substantially equivalent to previously cleared devices. The substantial equivalence is based upon equivalence in intended use, indications, anatomic sites, performance and material of manufacture." This indicates that the device was cleared based on its similarity to existing devices, not on a new performance study with explicit acceptance criteria.
§ 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.