Providence Medical Technology has announced it received FDA received 510(k) clearance for its PMT cervical cage. A press release reported that this approval completes the company’s current US product portfolio.
The PMT cervical sage is a novel minimally-invasive implant and delivery system for cervical fusion procedures in skeletally mature patients with degenerative disc disease of the cervical spine (C3-C7), with accompanying radicular symptoms at one disc level.
According to a company press release, this FDA clearance completes the company’s current US product portfolio, which also includes DTRAX Spinal System, DTRAX Graft, and PMT Bone Screws. DTRAX Spinal System and DTRAX Graft are on the market, and PMT Cervical Cage and PMT Bone Screws will launch the third quarter of 2013.
“Providence has now developed a broad minimally-invasive cervical product portfolio,” commented Jeff Smith, chief executive officer of Providence Medical Technology. “Our US launch of PMT Cervical Cage will build upon our successful international experience, where we have sold over 500 DTRAX Facet System units since its launch in Q4 of 2011. The clinical outcomes achieved by our customers and their patients have surpassed our expectations, and we are excited to bring this clinical value to US surgeons and patients.”