(68 days)
BoneSource® HAC Rapid Setting Cement is a self-setting, calcium phosphate cement intended for use in the repair of neurosurgical burr holes, contiguous craniotomy cuts and other cranial defects as well as in the augmentation or restoration of bony contour in the craniofacial skeleton.
BoneSource® HAC Rapid Setting Cement is a self-setting, calcium phosphate cement.
The provided text is a 510(k) summary for a medical device (BoneSource® HAC Rapid Setting Cement) and the FDA's clearance letter. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document states that the device is "substantially equivalent" to a predicate device (BoneSource® HAC (K032366)). This means that for a 510(k) submission, the manufacturer showed that their new device is as safe and effective as a legally marketed device, not that they performed a de novo study to establish new acceptance criteria and then met them.
Therefore, I cannot provide the requested information from the given input.
§ 882.5300 Methyl methacrylate for cranioplasty.
(a)
Identification. Methyl methacrylate for cranioplasty (skull repair) is a self-curing acrylic that a surgeon uses to repair a skull defect in a patient. At the time of surgery, the surgeon initiates polymerization of the material and forms it into a plate or other appropriate shape to repair the defect.(b)
Classification. Class II (performance standards).