Device typeImplantable craniofacial bone distractor: A non-powered implantable or partially-implantable device intended to temporarily distract (force apart) the two bone surfaces of the mandible (the lower jawbone) or maxilla (the upper jawbone) during craniomaxillofacial (CMF) distraction. It functions as a single-patient bone lengthening/augmentation device for the correction of congenital deficiencies or post-traumatic defects. It typically consists of a metal tube in which a right- and left-hand threaded rod rotates and to which are attached two craniofacial fixation plates that are surgically screwed to either side of the fracture. A small tip guard may be included to protect against inadvertent rotation.
FDA categoryCranial Distraction System
Device ID00888118114501
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyLabeling does not contain MRI Safety Information
Size30 MM, 31 HOLE