45b50839-96b9-423d-b15a-8c21a1ffb5aeUpdatePublished42022-04-262015-09-14In Commercial DistributionH981041031410SecondaryHIBCC10705034733272PrimaryGS1ANTEGRA04.103.14104103141486711679Synthes GmbH1TI ANTEGRA(TM) PLATE ONE LEVEL SACRAL/41MMfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(800)255-2500xx@xx.xxK06315800061325Bone-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 BODYfalsetrueMoist Heat or Steam Sterilization