53adf4b1-2040-4e96-8b91-d2c0fee1fe14UpdatePublished42025-07-022022-02-09In Commercial Distribution07640305163050PrimaryGS1PERLA ® TL MISMPF-SX 65 60-NMPF-SX 65 60-N483016148SpineArt SA1XTAB CANNULATED FENESTRATED SAGITTAL SCREW falsefalsefalsefalsefalsetruetruefalsetruefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse61325Bone-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 InterlaminalNKBThoracolumbosacral Pedicle Screw SystemLengthOuter DiameterfalsetrueMoist Heat or Steam Sterilization