Tag: FDA 510k
FDA provides additional 510(k) clearance for the ProLift expandable spacer system
Life Spine announced today that the US Food and Drug Administration (FDA) has provided additional 510(k) market clearance for the ProLift expandable spacer system.
“The...
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...
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)...