Tag: FDA 510k

OrthoPediatrics announces full-scale US launch of small stature scoliosis system

The RESPONSE 4.5/5.0mm System (OrthoPediatrics) has been launched in the USA. The company’s newest system, which received US Food and Drug Administration (FDA) 510(k)...

FDA 510(k) clearance for Astura Medical’s spinal fixation system

FDA 510(k) clearance has been granted for the Olympic minimally invasive surgery (MIS) posterior spinal fixation system (Astura Medical). The Olympic MIS system delivers a...
LifeSciences

FDA clearance granted for Hive-C cervical interbody devices

HD LifeSciences has received FDA 510(k) clearance for its Hive-C IBFD, a system of interbody devices for anterior cervical fusion procedures. The Hive-C implant system...

icotec receives FDA clearance to market BlackArmor® Carbon/PEEK interbody cages

The latest line of icotec interbody cages, designed to optimise bony integration and post-operative visualisation, has received US Food and Drug Administration (FDA) 510(k)...