41e7e4a3-af56-4f0a-8cb8-2fe384d8637fUpdatePublished22025-11-202025-06-24In Commercial Distribution08809595977818PrimaryGS1SignexA2B.08080688999370OSTEONIC CO.,Ltd.1falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK23054600046647Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.trueActiveHRSPlate, Fixation, BoneHWCScrew, Fixation, BonefalsetrueMoist Heat or Steam Sterilization