NanoHive Medical has received 510(k) clearance from the US Food and Drug Administration (FDA) for its Hive standalone cervical system. The implant system features both a zero profile design, interfixated with two self-tapping screws, as well as a cage and plate fixation option.
Both interbody cage options are available in multiple footprints, heights and lordoses to accommodate patient anatomy and feature the innovative Hive Soft Titanium technology.
Patrick O’Donnell, president & CEO of NanoHive Medical said: “This FDA clearance represents a very exciting and momentous achievement for the company. With the Q1, 2023 launch of the Hive standalone cervical system, combined with our Hive standalone anterior lumbar system, the company is positioned as the leader of 3D-printed titanium anterior standalone fusion systems. Additionally, the new cervical system is ideally designed to address the rapid migration of cervical fusion procedures to ambulatory care surgery centre facilities.”