b77d991f-d453-458f-8be3-531bf3ccf89fUpdatePublished62025-07-022019-02-18In Commercial Distribution00840606106986PrimaryGS1LOTUS32521-000610712213SPINAL ELEMENTS, INC.1Hook, 5mm Straight truefalsefalsefalsefalsetruetruefalsetruefalsefalsetruefalseLabeling does not contain MRI Safety Informationtruefalse+1 (760) 607 0121info@spinalelements.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.falseObsoleteKWPAppliance, Fixation, Spinal InterlaminalfalsetrueMoist Heat or Steam Sterilization