f1337511-ce04-4cbb-9321-a57b0021c76eUpdatePublished32018-07-062017-02-06In Commercial Distribution00815101026121PrimaryGS1PCTPCT06ST005949024850Centinel Spine, Inc.1falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK15221100061325Bone-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.trueActiveNKGOrthosis, Cervical Pedicle Screw Spinal FixationKWPAppliance, Fixation, Spinal InterlaminalfalsetrueMoist Heat or Steam Sterilization