333b7ea1-a60c-4318-8537-1c7ec591d0d7UpdatePublished32020-02-242016-09-27In Commercial Distribution11990210Direct MarkingHIBCCM364119902FD100PrimaryHIBCCAsfora Bullet CageĀ® System 11-9902-FD10003815548MEDICAL DESIGNS LLC118mm x 25mm Cage; The Asfora Bullet CageĀ® is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.falsefalsefalsefalsefalsetruetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse605-275-1032kspielman@medicaldeisgnsllc.com38161Metallic spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of metal [e.g., titanium (Ti)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.trueActiveMAXIntervertebral Fusion Device With Bone Graft, LumbarOuter DiameterLengthtruefalse