5e44efa5-3899-4108-9c02-c6278d76f176UpdatePublished32020-02-052016-11-03In Commercial DistributionB030ORO8530R0PrimaryHIBCCORTHROSORO-8530R054205979CAMBER SPINE TECHNOLOGIES, LLC1Ø8.5mm polyaxial reduction pedicle screw , 30mm lg.falsefalsefalsefalsefalsetruetruefalsetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse1-866-643-0739customerservice@cambermedtech.com61325Bone-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.trueActiveKWQAppliance, Fixation, Spinal Intervertebral BodyMNHOrthosis, Spondylolisthesis Spinal FixationMNIOrthosis, Spinal Pedicle FixationNKBOrthosis, Spinal Pedicle Fixation, For Degenerative Disc DiseaseOuter DiameterLengthfalsetrueMoist Heat or Steam Sterilization