4a5447f4-bfd1-4d1d-add7-dc82c3b33237UpdatePublished82025-11-202017-02-28In Commercial Distribution90814008023281PrimaryGS1tangisACP-1-34ACP-1-34047486041NVISION BIOMEDICAL TECHNOLOGIES, INC.1Anterior Cervical Plating System, 1 level implant. The Tangis Anterior Cervical Plate is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fusion of the cervical spine (C2 to T1). The system is indicated for use in the temporary stabilization of the anterior spine during the development of cervical spinal fusion in patients with: • degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), • spondylolisthesis, • trauma (i.e. fractures or dislocations), • tumors, • deformity (defined as kyphosis, lordosis, or scoliosis), • pseudarthrosis, • failed previous fusion, • spinal stenosistruefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse210-545-3713diana@nvisionbiomed.comK16152400046653Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization as part of treatment of a spinal instability or deformity; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.trueActiveKWQAppliance, Fixation, Spinal Intervertebral BodyHeightWidthDepthfalsetrueMoist Heat or Steam Sterilization