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 categoryDevice, Germicidal, Ultraviolet, Orthosis, Spinal Pedicle Fixation, Orthosis, Spondylolisthesis Spinal Fixation, Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis, Thoracolumbosacral Pedicle Screw System
Device ID00840314120342
Catalog numberCBEAJ-55029
AvailabilityPrescription
Single useYes
MRI safetyLabeling does not contain MRI Safety Information