Search Results

The Cranial LOOP Cranial Bone Fixation Systems: Cranial LOOP (L) and Cranial Loop (XL), are longterm implantable devices indicated for post-craniotomy bone flap fixation.

In cranial bone fixation procedures, the Cranial LOOP (FC050000) and Cranial LOOP (L) (FC050100) are for use within the osteotomy line (calvarial gap) while the Cranial LOOP (XL) (FC050200) is to be used for covering a standard 14 mm cranial burr hole only.

The Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System is a biocompatible, postoperative cranial bone fixation system that fixes the bone flap to the skull, without any specific surgical instrument for its handling or implantation. It is provided sterile, for single use. Cranial LOOP and Cranial LOOP L are applied in the craniotomy gap. They can fix cranial thicknesses ranging from 1.5 mm to 24 mm and gaps ranging between 1.7 mm and those made using a craniotome standard cranial router. Cranial LOOP XL is applied in a burr hole made using a standard drill 14 mm. They can fix cranial thicknesses ranging from 4mm to 24 mm.

The request cannot be fulfilled as no information regarding acceptance criteria, study details, sample sizes, expert involvement, or specific ground truth methods is provided for an AI/CADe device. The provided text is a 510(k) clearance letter for a cranial bone fixation system, which is a physical implant, not a software or AI device. The document explicitly states "No clinical testing was performed to support this submission." and focuses on "Biomechanical and functional testing" for a physical device.

Ask a specific question about this device