77636433-b5b8-4bfd-b5ae-ec0097ac6664UpdatePublished32020-02-052015-10-26In Commercial DistributionB030CP006450PrimaryHIBCCOrthrosØ8.5mm Cannulated Polyaxial Pedicle Screw, 90mm Lg. CP-006-45054205979CAMBER SPINE TECHNOLOGIES, LLC1falsefalsefalsefalsefalsetruetruefalsetruefalsefalsefalsetrueLabeling does not contain MRI Safety Informationtruefalse61325Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.trueActiveNKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc DiseasefalsetrueMoist Heat or Steam Sterilization