64be345f-b830-457f-8e2e-fb6cdbdc2e4dNewPublished12026-05-192026-05-11In Commercial Distribution08809233628362PrimaryGS1ACR Bone PlateZL2004-405-310689679066BioMaterials Korea, Inc.1falsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationfalsefalseK11092600046642Craniofacial fixation plate, non-bioabsorbable, non-customizedA 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.trueActiveJEYPlate, BonefalsetrueMoist Heat or Steam Sterilization