Device typeCraniofacial fixation plate, non-bioabsorbable, non-customized: A small, implantable, non-customized sheet of firm material designed to be attached with screws to craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize a fracture gap or craniotomy flap, cover a burr hole and/or position/stabilize a prosthesis. It is made of non-bioabsorbable materials (e.g., surgical steel, titanium alloy) and is available in a variety of designs (e.g., Y-plate, curved plate, mesh-panel, burr hole cover). Instruments intended to facilitate implantation (e.g., driver), or plate fixation implants (i.e., bone screws), may be packaged with the plate.
FDA categoryPLATE, BONE
Device ID00888118125057
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional
Size5 HOLE, T=1.0 MM