37b7e989-a101-4f55-aa87-2ea036c8ae68UpdatePublished22025-07-022024-09-06In Commercial Distribution00840314168221PrimaryGS1Nex-D2CBFDJ-60075CBFDJ-60075046767258NEXT ORTHOSURGICAL, INC.1HIGH-TOP POLYAXIAL CANNULATED SCREW, ST, Ø6.0mm x 75mm falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK14129100061325Bone-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.falseObsoleteNKBThoracolumbosacral Pedicle Screw SystemOSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisMNIOrthosis, Spinal Pedicle FixationMNHOrthosis, Spondylolisthesis Spinal FixationOuter DiameterLengthfalsetrueMoist Heat or Steam Sterilization