Device typeBone-screw internal spinal fixation system, sterile: An assembly of 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. Sterile disposable devices associated with implantation may be included.
FDA categoryOrthosis, Spinal Pedicle Fixation, Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease, Orthosis, Spondylolisthesis Spinal Fixation
Device ID07640159551546
AvailabilityPrescription
Single useYes
SterileYes
MRI safetyMR Safe