Providence Medical Technology Gains FDA Clearance for DTRAX Spinal System

By Julie A. Vetalice

Providence Medical Technology received FDA 510(k) clearance to market its DTRAX® Spinal System for use in posterior cervical fusion in patients with degenerative disc disease. This 510(k) provides a more specific indication for DTRAX, which was a Class I device with a broad indication for fusion.

The DTRAX Spinal System is reportedly the only sterile-packaged, single-use set of instruments specifically cleared for posterior cervical fusion.

The DTRAX Spinal System received CE Mark approval in 2015 and Australia Regulatory Approval in 2017. The company's portfolio includes ALLY Posterior Fixation system, ALLY Bone and facet screws and CAVUX cervical cages.

Sources: Providence Medical Technology; ORTHOWORLD Inc.

Providence Medical Technology DTRAX Spinal System

Image courtesy of Providence Medical Technologies

Product Labels: Spinal Fusion

Tags: 510(k) Clearance, Regulatory