e193c1bd-1915-4f84-9b2e-a95ab5dbc225UpdatePublished32025-03-192020-08-28In Commercial DistributionB565FZI0490PrimaryHIBCCFuse Pedicle Screw System Rev AFZ-I-049017138000CPM Medical Consultants, LLC1T Handle Ratchet 1/4 Cannulated falsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse972-331-5860xx@xx.xxK18228300047829Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. This is a reusable device.falseActiveNKBThoracolumbosacral Pedicle Screw SystemfalsetrueMoist Heat or Steam Sterilization