Ascendx Spine, focused on the development and commercialization of innovative orthopedic devices for the spine and trauma markets, has received CE mark and ISO 13485 certification for its VCF Repair System and Acu-Cut Vertebral Augmentation System.
Ascendx VCF Repair System is used to treat vertebral compression fracture (VCF).
Ascendx Spine CEO Julian Mackenzie said the VCF Repair System and the Acu-Cut Augmentation System are designed for the treatment of spinal fractures by spine surgeons and interventional radiologists.
"The company also has a 510(k) submission pending FDA clearance for its VCF Repair System and a 60-patient, multicenter US clinical trial has been successfully completed," Mackenzie said.