Device typeBone-screw internal spinal fixation system, non-sterile: An 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.
FDA categoryPedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device ID03613720180555
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information