Danish medical device company FBC Device has obtained CE Mark approval for its Statur-L, a spinal fusion implant.
FBC Device has also obtained International Organization for Standardization certification for maintaining highest quality standards.
The Statur-L is a hybrid of fusion and non-fusion technology and allows surgeons gain a better way to address the loss of spinal curvature in patients undergoing fusion.
Novel design of the device reduces the number of implants required.
FBC Device has recently presented data supporting the positive nature of the Statur-L at EuroSpine Annual Meeting in Liverpool and the German Congress of Orthopaedics and Trauma in Berlin.
Statur-L, in a research, is found to be capable of reducing relative movement between the implant and the spinal bone, ensuring that the surgeon’s restoration of curvature during surgery is not lost following surgery.
FBC Device founder and CEO Dr Finn Bjarke Christensen noted the company is very pleased to have achieved both ISO 13485 and CE mark.
"We are committed to produce innovative and high quality spinal implants supported by significant experimental and clinical documentation. The ISO certification evaluates the business’s adherence to quality standards, while the CE mark ensures that the device conforms to safety and performance requirements.
"Attaining CE mark on our first product line allows us to start clinical activity at leading European spine centers to document the benefits for chronic low back pain patients, surgeons and hospitals," Christensen added.
With the CE Mark approval, the company can now launch Statur-L in European and Canadian markets.