(77 days)
CustomizedBone Service (CustomizedBone) is intended to replace bony voids in the craniofacial skeleton (frontal bone including the brow ridge) . This device is indicated for both adult and pediatric use (for children 7 years of age and above).
CustomizedBone implants are suitable for reconstructing craniofacial defects resulting from:
- · trauma and vascular pathologies, either associated or non-associated to cranial decompression;
- · removal of tumours:
- · reabsorption of autologous bone;
- · rejection of other prosthetic materials;
- · congenital malformations.
Not Found
This document is a 510(k) clearance letter from the FDA for the "CustomizedBone Service" device. It does not contain the detailed acceptance criteria and study information typically found in a clinical study report or a 510(k) summary (which might be a separate document). The letter primarily addresses the substantial equivalence determination and regulatory requirements for marketing the device.
Therefore, I cannot provide the requested information about acceptance criteria and the study proving the device meets those criteria from this text. The provided document is a regulatory approval letter, not a study report.
To answer your questions accurately, I would need access to the 510(k) summary or the full submission documentation, which would describe the performance testing conducted for the "CustomizedBone Service."
§ 882.5330 Preformed nonalterable cranioplasty plate.
(a)
Identification. A preformed nonalterable cranioplasty plate is a device that is implanted in a patient to repair a skull defect and is constructed of a material, e.g., stainless steel or vitallium, that cannot be altered or reshaped at the time of surgery without changing the chemical behavior of the material.(b)
Classification. Class II (performance standards).