655b7583-2749-472e-9b5a-9872dd8f4e1bUpdatePublished32018-07-062015-10-24In Commercial Distribution00887517215277PrimaryGS1SpheRx4485545053950783Nuvasive, Inc.1DBR® III Screw, 5.5x45mm CannulatedfalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(858)909-1800RA_UDI@nuvasive.comK08302800061325Bone-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.trueActiveMNHOrthosis, spondylolisthesis spinal fixationKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYMNIORTHOSIS, SPINAL PEDICLE FIXATIONKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALNKBOrthosis, spinal pedicle fixation, for degenerative disc diseasefalsetrueMoist Heat or Steam Sterilization