f4eeb750-f6e6-453c-919e-72f838fbcdb2UpdatePublished32018-07-062015-10-24In Commercial Distribution00887517098979PrimaryGS1SpheRx7756535053950783Nuvasive, Inc.1PPS Screw Shank, 6.5x35mm CannulatedfalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(858)909-1800RA_UDI@nuvasive.comK09098100061325Bone-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 fixationKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALNKBOrthosis, spinal pedicle fixation, for degenerative disc diseaseKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYMNIORTHOSIS, SPINAL PEDICLE FIXATIONfalsetrueMoist Heat or Steam Sterilization