8b28e681-8a26-4b45-a4a5-90ef5ee108f0UpdatePublished22018-03-292017-01-13In Commercial DistributionB06210022150PrimaryHIBCCBlack Diamond Pedicle Screw System1002-21501002-2150933442068Osseus Fusion Systems, LLC1ROD, CURVED, PERC, 5.5x150mm, BLK DIAMOND
falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse888-330-5960Info@osseus.com61325Bone-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 FixationMNIOrthosis, Spinal Pedicle FixationLengthOuter DiameterfalsetrueMoist Heat or Steam Sterilization