85ff66f9-b10f-414f-be4c-86f62e9d74b3UpdatePublished72025-11-202015-10-24In Commercial Distribution00880304491908PrimaryGS1DYNAFIX VS OSTEOTOMY SYSTEM10112P10112P129278169Biomet Orthopedics, LLC1falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)348-9500customerservice@zimmerbiomet.comK01055100046647Orthopaedic 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.trueActiveNDHNAIL, FIXATION, BONE, METALLICNDFPLATE, FIXATION, BONE, NON-SPINAL, METALLICDevice Size Text, specify11.25 MM 4 HOLEfalsetrueMoist Heat or Steam Sterilization