f566f7a8-20b3-4a1d-8102-ff0aeaed1a3cUpdatePublished32018-07-062015-10-24In Commercial Distribution00887517198587PrimaryGS1ReLine11044050053950783Nuvasive, Inc.1GSB Screw, 4.0x50mm 2S UniplanarfalsefalsefalsefalsefalsefalsetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(858)909-1800RA_UDI@nuvasive.comK13201400061325Bone-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 BODYNKBOrthosis, spinal pedicle fixation, for degenerative disc diseaseMNHOrthosis, spondylolisthesis spinal fixationMNIORTHOSIS, SPINAL PEDICLE FIXATIONKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALfalsetrueMoist Heat or Steam Sterilization