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The Peekplus® Interbody Fusion Device ("Peekplus Device") is indicated for use in patients with degenerative disc disease (DDD) at one (1) or two (2) contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have had a previous non-fusion spinal surgery at the involved level(s) and may have had up to a Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). The Peekplus® devices are to be used with autogenous bone graft material and supplemental fixation.

The Peekplus® Interbody Fusion Device is manufactured for Vallum Corporation by Binder Biomedical. Inc. and is identical to the Intervertebral Body Fusion Device cleared in K093015. The Peekplus® is comprised of a series of PEEK-OPTIMA® spacers shaped to accommodate autogenous bone graft and anatomical variation at different spinal levels. The Peekplus® also has a series of ridges on its superior and inferior surfaces to improve fixation and prevent migration. The Peekplus® is provided non-sterile.