4575370a-43c9-433c-9194-76ffee703279UpdatePublished62025-10-242016-09-02In Commercial Distribution10889981069605PrimaryGS1Mariner41-9020-141-9020-1079840876Seaspine Orthopedics Corporation1Solid Screw 9.00 x 20mmfalsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+1(760)727-8399custsvcspine@seaspine.comK16090200061325Bone-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.falseObsoleteNKBOrthosis, spinal pedicle fixation, for degenerative disc diseaseMNHOrthosis, spondylolisthesis spinal fixationKWQAPPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODYMNIORTHOSIS, SPINAL PEDICLE FIXATIONDevice Size Text, specify9.00 x 20mmfalsetrueMoist Heat or Steam Sterilization