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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.

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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."

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