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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 Cranial COVER is intended for use to cover burr holes resulting from cranial surgery. With the available sizes, burr holes with an epicranial diameter between 10 and 14 mm, made with standard perforators or with spherical drills, can be covered.

The Cranial COVER is a postoperative biocompatible cranial burr hole cover system. It fits into most common cranial burr holes, and its upper platform is in contact with the skull surface. It avoids the anti-cosmetic postoperative skin concavities. It does not require any specific surgical instrument for its handling or implantation. It is provided sterile, for a single use. Two different sizes are presented: - . FC050300, large size, for the most common burr holes, made with standard perforators (diameters 14/11 mm or 13/9 mm1). - . FC050400, small size, for small burr holes (diameters from 12 mm to 10 mm), made with spherical drills. The device functions like a clamp. An upper (epicranial) and a lower (subcranial) platform, joined by two cable ties, are tightened together with the help of non-implantable elements (handle and applier) and cover the burr hole.

The Cranial LOOP Cranial Bone Fixation Systems: Cranial LOOP, Cranial LOOP L and Cranial LOOP XL, are long-term 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 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. This submission includes a line extension for the Cranial LOOP L and Cranial LOOP XL which have new device dimensions and design features that reduce lateral movement after implantation. Cranial LOOP and Cranial LOOP L are applied in the craniotomy gap. It 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 4 mm to 24 mm.

The Cranial LOOP Cranial Bone Fixation System is a long-term implantable device indicated for post-craniotomy bone flap fixation.

The Cranial LOOP 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.