0a67fc68-9f41-408d-b6fd-602a0a36789cUpdatePublished32024-11-252018-12-12In Commercial DistributionM697C01000860Direct MarkingHIBCCM697C01000861PrimaryHIBCCXpress Minimally Invasive Pedicle Screw SystemC022-0018081224143Xtant Medical Holdings, Inc.14-Slot Counter TorquefalsetruefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(888)886-9354cs@xtantmedical.com47554Orthopaedic counter-torque/rod-pushing instrumentA hand-held, manual, tube-like surgical instrument with a right-angled handle designed to apply a rotational force that opposes the directional force of torque when tightening (locking) a screw or screw head setscrew with a screwdriver, inserted down the instrument's hollow centre, during orthopaedic surgery. In addition, it may be used to push (seat) an orthopaedic rod into the slotted screw heads of screws that have been inserted into bone (e.g., vertebrae). It is typically made of high-grade stainless steel or titanium alloy, and synthetic materials. This is a reusable device.falseActiveMNIOrthosis, spinal pedicle fixationMNHOrthosis, spondylolisthesis spinal fixationfalsetrueMoist Heat or Steam Sterilization