68a36104-67b5-4cec-bff9-0aed7b038132UpdatePublished32018-07-062015-10-24In Commercial Distribution00887517104793PrimaryGS1SpheRx7767575053950783Nuvasive, Inc.1SpheRx® PPS Shank, 7.5x75mm Non-CannfalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling 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 fixationMNIORTHOSIS, SPINAL PEDICLE FIXATIONNKBOrthosis, spinal pedicle fixation, for degenerative disc diseaseKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYfalsetrueMoist Heat or Steam Sterilization