Australia Regulatory Approval for Providence Medical’s DTRAX Cervical Fusion Devices

By Julie A. Vetalice

Providence Medical Technology (PMT) received regulatory approval from the Australian Therapeutic Goods Administration for DTRAX® implants and instruments, used in tissue-sparing posterior cervical fusion.

Products cleared under the approval include GL-DTRAX Spinal System, GL-DTRAX Cervical Cage-T, GL-DTRAX Cervical Cage-B, GL-DTRAX Expandable Cage and the GL-DTRAX Bone Screw.

PMT plans to submit products to the Prostheses List in 3Q17 for inclusion in early 2018. (In Australia, the Prostheses List details surgically implanted prostheses, human tissue items and other medical devices for which private health insurers must pay benefits when these items are provided to a patient with appropriate health insurance as part of hospital or hospital substitute treatment, when there is a Medicare benefit payable for the professional service.)

Sources: Providence Medical Technology, Inc.; The Australian Government Department of Health

Product Labels: Cervical Spine, Spinal Fusion

Tags: Regulatory