8c860e90-d5b1-4139-94b8-de7916b6cf45UpdatePublished52018-07-312015-09-242018-07-31Not in Commercial Distribution10705034054841PrimaryGS1MONARCH177036260177036260107105876DEPUY SPINE, LLC1MONARCH SPINE SYSTEM PEDICLE SCREW, POLYAXIAL 6.35 x 6.25 x 60mmfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)255-2500xx@xx.xxK01057600061325Bone-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.trueActiveMNIORTHOSIS, SPINAL PEDICLE FIXATIONMNHOrthosis, spondylolisthesis spinal fixationKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALfalsetrueMoist Heat or Steam Sterilization