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This device is intended for use in internal fixation of small bones including the craniomaxillofacial skeleton and hand secondary to trauma or for reconstruction.

This submission describes self drilling bone screws intended for use in internal fixation of small bones including the craniomaxillofacial skeleton and hand, secondary to trauma or for reconstruction. The Self Drilling Screw is available in 1.2 and 1.7 mm diameters with lengths ranging from 4-7 mm and in a 2.0 mm diameter with lengths ranging from 5-8 mm.

This product is intended for use in the treatment of cranial, midface, or mandibular conditions for which reconstructive oscotomy and segment are indicated. This includes conditions such as, syndromic cramosynostosis, midfacial cetrusion, hemifacial microsomia, und mandibular micrognathia. The device is mended to provide temporary stabilization and gradual lengthening of the cranial, midfacial, or mandibular bones

This device is a distraction system consisting of the following major components; distractor frame, plates, machine screws, flexible shaft, and distraction key. The plates and frame initially stabilize and then gradually distract the osteotomy. The flexible shaft, covered with a protective sheath, is connected to the frame and provides the point of attachment for the key used to initiate the distraction of the osteotomy.

This product is mended for use in the treatment of cranial, midface, or mandibular conditions for which reconstructive osteolority and segment advancement are indicated. This includes conditions such as, syndromic craniosynostosis, midfacial retrusion, hemifacial microsomia, and mandibular microgradhia. The device is monded to provide temporary stubilization and gradual lengthening of the crawial, midfacial, or mandibular bones.

This device is a distraction system consisting of the following major components; distractor frame, extension rods, connector forks, distraction port or flexible shaft and distraction key. Depending on the frame is connected to either a distraction port or a flexible shaft, which is covered with a protective sheath.

The Epitec system can be used for the fixation of diverse kinds of craniofacial prostheses, including the following examples: - Ear prostheses Orbital prostheses Nose prostheses Cheek prostheses Hair Pieces Although the Epitec system will primarily be used for the alloplastic reconstruction of craniofacial defects caused by genetic anomalies, tumor resections, or trauma, it can also be used in other craniofacial cases best treated with surgical anchoring.

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This submission describes a small bone screw intended for use in temporary maxillomandibular fixation to provide indirect stabilization of the maxilla, mandible, or both.

The Leibinger® IMF Screw is 2.0 mm in diameter and ranges from 10.5-18.5 mm in total length (6-14 mm in threaded length). There is a hole in the screw head through which a wire can be passed to fix the maxilla and mandible. The device is for single use only.

The Lee Plate is intended for use in internal fixation of corrective osteotomies to the symphysis region of the mandible (genioplasty procedures). The basic operational principle is to provide fixation/stabilization of an anterior mandibular bone segment that is freed during a corrective osteotomy procedure.

This submission describes a bone plate intended for use in internal fixation of corrective osteotomies to the symphysis region of the mandible (genioplasty procedures). It is designed to provide fixation to an advanced anterior mandibular bone segment. Screw holes allow for attachment to the anterior mandible and the osteotomized segment. 1.7 mm and 2.0 mm diameter screws are used to attach the plate to bone.

intended for use in internal fixation of small bones including the craniomaxillofacial skeleton secondary to trauma or for reconstruction.

This submission describes a system of small bone screws. Screws are available in diameters ranging from 0.8 to 2.4 mm and lengths ranging from 2 mm to 28 mm. These devices are for single use only.

This submission describes an intraoral distraction device. It is intended for use as a mandibular bone lengthener for patients diagnosed with conditions where treatment includes mandibular distraction osteogenesis. These conditions may include diagnoses such as mandibular micrognathia or hemifacial microsomia.

The device consists of three major components: the threaded self drilling fixation pins, the mandibular distraction frame and the distraction rod and key. The pins attach the frame to the mandible. The distraction rod attaches to the frame and is rotated via the key to apply tension to the frame and osteotomy site. Directions regarding distraction are given to the patient by the physician. Frames are available for up to 18 mm or 28 mm of distraction depending upon the condition of the mandible. All components of this device are for single use.

It is intended for use in internal fixation of small bones including the hand and foot secondary to trauma or for reconstruction.

This submission describes a system of small bone screws. Screws are available in diameters ranging from 0.8 to 3.5 mm and lengths ranging from 2 mm to 40 mm. These devices are for single use only.