f5682ad8-f642-43c9-96f1-c25601b1f53cUpdatePublished52025-11-202016-09-27In Commercial Distribution111106375Direct MarkingHIBCCM364111106FD3750PrimaryHIBCCAsfora Anterior Cervical Plate System11-1106-FD3-75003815548MEDICAL DESIGNS LLC13 Level, 75mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporary stabilization to the anterior spine during the development of cervical spine fusions (C2-T1) for the following indications: degenerative disc disease (DDD) (defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.falsefalsefalsefalsefalsetruetruefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse605-275-1032kspielman@medicaldesignsllc.comK14368800046653Spinal 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 BodyfalsetrueMoist Heat or Steam Sterilization