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 categoryHearing aid, bone conduction, implanted
Device ID09321502043908
Catalog numberP1340893
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
SizeImplant 4 mm with 14 mm Abutment
Length14 Millimeter