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, CRANIOPLASTY, PREFORMED, NON-ALTERABLE
Device ID04038653379576
Catalog numberFF490T
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Conditional