541dca8b-6275-4a5e-90fc-41c01d06a15bUpdatePublished52018-07-062015-09-242018-06-20Not in Commercial Distribution10705034389141PrimaryGS1PULSE310101530S310101530S482661753Medos International Sàrl1PULSE LUMBAR SCREW SYSTEM POLYAXIAL SCREW 5 x 30mmfalsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)255-2500xx@xx.xxK11339600061324Bone-screw internal spinal fixation system, sterileAn assembly of 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. Sterile disposable devices associated with implantation may be included.trueActiveMNIORTHOSIS, SPINAL PEDICLE FIXATIONKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYMNHOrthosis, spondylolisthesis spinal fixationNKBOrthosis, spinal pedicle fixation, for degenerative disc diseaseKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALtruefalse