cb75c972-dcf2-4518-bdd5-8d17d36ac1b8UpdatePublished32022-04-262015-09-14In Commercial DistributionH981SD4960030SecondaryHIBCC10705034709888PrimaryGS1NASD496.003SD496003486711679Synthes GmbH18.0MM TI SACRAL WASHERfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)255-2500xx@xx.xx61325Bone-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.trueActiveJDWPIN, FIXATION, THREADEDfalsetrueMoist Heat or Steam Sterilization