Sam Brusco, Associate Editor02.05.21
Precision Spine Inc. has been granted 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Dakota ACDF Standalone System to treat of degenerative disc disease (DDD). It features a titanium plate polyetheretherketone (PEEK) cage with cortical cancellous screws and a generous cavity for autogenous bone graft.
“With the inclusion of differentiating dual thread screws and high screw angulations, the Dakota ACDF system offers superior fixation and stability,” Payam Farjoodi, M.D. from Coastline Orthopaedic Associates told the press. “The unsurpassed ease of use provided by the intuitive instrumentation makes it an ideal system for even the most challenging cases.”
“The Dakota ACDF System represents another example of how Precision Spine is making good on its commitment to develop surgeon-designed devices that embody the advanced features surgeons need to help improve OR efficiency and achieve positive patient outcomes,” added Precision Spine COO Chris DeNicola.
The Dakota ACDF System is indicated for use in skeletally mature patients with cervical spine (C2-T1) DDD at one or two disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Dakota ACDF is placed via an anterior approach at the C2 to T1 disc levels.
“With the inclusion of differentiating dual thread screws and high screw angulations, the Dakota ACDF system offers superior fixation and stability,” Payam Farjoodi, M.D. from Coastline Orthopaedic Associates told the press. “The unsurpassed ease of use provided by the intuitive instrumentation makes it an ideal system for even the most challenging cases.”
“The Dakota ACDF System represents another example of how Precision Spine is making good on its commitment to develop surgeon-designed devices that embody the advanced features surgeons need to help improve OR efficiency and achieve positive patient outcomes,” added Precision Spine COO Chris DeNicola.
The Dakota ACDF System is indicated for use in skeletally mature patients with cervical spine (C2-T1) DDD at one or two disc levels. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. Dakota ACDF is placed via an anterior approach at the C2 to T1 disc levels.