NanoHive Medical has obtained 510(okay) clearance from the U.S. Food and Drug Administration (FDA) for its 22mm size Hive™ PL Interbody System. The 22mm size implants are a line extension to the present Hive PLIF interbody units and have a 9mm width and number of peak and lordotic choices to accommodate affected person anatomy.
Moreover, the regulatory clearance consists of up to date description of the microscopic roughened surfaces with micro and nano-scale options discovered on all surfaces of the Hive Gentle Titanium® interbodies, together with the superior, inferior, and peripheral surfaces, in addition to every member of the interior cell construction.
The corporate’s Hive Lumbar Interbody System, with a microscopic roughened floor and micro and nano-scale options, is indicated to be used in skeletally mature sufferers with Degenerative Disc Illness (DDD) at one or two contiguous ranges from L2-S1. The system have to be used with supplemental fixation, with autograft or allograft bone.
About NanoHive Medical LLC
NanoHive Medical, LLC is a pioneer and main innovator in 3D printed spinal interbody fusion implants and instrumentation. The corporate’s proprietary, biomimetic Gentle Titanium® know-how clearly distinguishes their merchandise within the $1.9B spinal interbody fusion machine market. The Hive™ portfolio of interbody fusion units presents surgeons and sufferers a set of remarkable traits, together with optimum biomechanical elastic modulus properties, exact diagnostic imaging capabilities, and splendid osteoblast cell attraction and integration qualities. These options could constantly contribute to robust fusion constructs and optimistic scientific experiences.
NanoHive Medical is situated in Woburn, Massachusetts U.S.A.
Contact: Patrick O’Donnell, CEO & President, Patrick.firstname.lastname@example.org Web site: www.nanohive.com