Precision Spine Receives FDA 510(K) Clearance for Dakota ACDF Standalone System

By Julie A. Vetalice

Precision Spine Receives FDA 510(K) Clearance for Dakota ACDF Standalone System

Precision Spine was granted FDA 510(k) clearance to market the Dakota ACDF™ Standalone System to treat degenerative disc disease.

Precision Spine Dakota ACDFDakota ACDF comprises a titanium plate polyetheretherketone cage with cortical cancellous screws and a large cavity for autogenous bone graft to support fusion.

The device is placed via an anterior approach at the C2 to T1 disc levels. Patients should have at least six weeks of non-operative treatment prior to treatment with an intervertebral fusion device.

“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,” said Chris DeNicola, Chief Operating Officer of Precision Spine.

Product Labels: Cervical Spine, Spinal Fusion

Tags: 510(k) Clearance, Regulatory