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 categoryEXTERNAL MANDIBULAR FIXATOR AND/OR DISTRACTOR
Device ID00841036010836
Catalog number01-3550
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information