abb081c1-3449-44c1-a8cb-ecb0c22a81e6UpdatePublished52018-07-062015-09-242018-06-20Not in Commercial Distribution10705034054155PrimaryGS1MONARCH177027050177027050107105876DEPUY SPINE, LLC1MONARCH SPINE SYSTEM STANDARD PEDICLE SCREW 7 x 50mmfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling 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.trueActiveMNHOrthosis, spondylolisthesis spinal fixationKWPAPPLIANCE, FIXATION, SPINAL INTERLAMINALMNIORTHOSIS, SPINAL PEDICLE FIXATIONfalsetrueMoist Heat or Steam Sterilization