From Mauna Kea receiving FDA clearance to Medacta getting clearance for its pedicle screw placement guide, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. Mauna Kea wins FDA nod for neurosurgery indication Mauna Kea announced in a May 24 press release that it has received FDA 510(k) clearance […]
Implanet
Implanet inks distro deal with Korea’s L&K Biomed
France-based orthopedic implant company Implanet said today that it inked a strategic partnership with Korea’s L&K Biomed. According to the terms of the deal, Implanet America will team up with Aegis Spine, L&K Biomed’s U.S. subsidiary, to accelerate the marketing of its Jazz platform in the U.S. In Asia, L&K Biomed will be responsible for distributing […]
7 medtech stories we missed this week: Oct. 27, 2017
From RadiaDyne’s FDA expansion to NuVasive launching its new implants, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA expands indications for RadiaDyne’s OARtrac dose monitor RadiaDyne announced in an Oct. 24 press release that it has received additional FDA clearance for its upcoming OARtrac. The OARtrac allows […]
Implanet wins CE Mark, FDA nod for next-gen Jazz braid
French orthopedic implant company Implanet said today it has won CE Mark approval in the European Union and FDA clearance for its Jazz braid device designed for use with the company’s proprietary Jazz tensioning system. The company said that the new Jazz braid includes improvements based on surgeon feedback it has received since the initial product’s launch […]
Implanet wins expanded FDA 510(k) for Jazz band device
French orthopedic implant company Implanet said Wednesday it won expanded FDA 510(k) clearance for its Jazz spinal implant allowing it to be used with other posterior thoraco-lumbar fixation systems. The Jazz implant is intended to provide temporary stabilization as a bone anchor during bone fusions and to aid in the repair of bone fractures. The […]