bd41fab5-1d21-4e81-b26a-3030d315cc20UpdatePublished22020-01-202018-12-15In Commercial Distribution00814008028672PrimaryGS1FOCUSPDCR-550-025047486041NVISION BIOMEDICAL TECHNOLOGIES, INC.1PS, MIS-Tower Reduction, Cannulated Cortical Cancellous 5.5X25mm. The FOCUS Pedicle Screw System is intended for use in the non-cervical posterior spine (T1-S1) to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, fracture, dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), spinal stenosis, tumor, pseudarthrosis, and failed previous fusion.truefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse210-545-3713Diana@nvisionbiomed.comK18045800061325Bone-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.trueActiveNKBThoracolumbosacral Pedicle Screw SystemLengthOuter DiameterSpecial Storage Condition, SpecifyA complete case with devices and instruments should not exceed 25 lbs and cases should not be stacked at anytime.falsetrueMoist Heat or Steam Sterilization