Salvin Dental Specialties

Device typeCraniofacial bone screw, non-bioabsorbable: A small, threaded rod with a slotted and/or polygonal (e.g., hexagonal) head intended to be implanted in craniofacial bone (including the maxilla and/or mandible) for fracture fixation by direct interfragmentary stabilization of bone or by screwing plates in place; it may also be intended for transplanted bone fixation. It may be self-drilling/self-tapping and is made of a material that is not chemically degraded or absorbed via natural body processes [e.g., implant grade metal such as titanium (Ti)]. Its uses include repair of orbital fractures and fractures around the cranial sinuses, paediatric reconstructive surgery, craniotomy flap fixation, bone augmentation procedures.

FDA categoryScrew, Fixation, Intraosseous

Device ID00841336100077

AvailabilityPrescription

Single useYes

SterileYes

MRI safetyLabeling does not contain MRI Safety Information