Aurora Spine earned FDA 510(k) clearance for its Aero facet fusion system, the devicemaker said March 25. Aero is a minimally invasive system for facet joint-related pain or instability in levels C2 to S1, according to a news release. It…
Spinal Tech
Tenon Medical earned FDA 510(k) clearance to use its Catamaran sacroiliac joint system for augmenting thoracolumbar fusion, according to a March 24 news release. With the new indication Catamaran can be used as a standalone treatment or to augment spinal…
SynerFuse is partnering with Velentium Medical to scale the SynerFuse e-TLIF implant, according to a March 21 news release. Velentium Medical will support SynerFuse with strategic development and manufacturing. SynerFuse’s e-TLIF requires one incision and integrates neuromodulation with spinal decompression…
SurGenTec announced that OsteoFlo HydroFiber, its synthetic bone graft solution equivalent to autograft, is now being used in spinal surgeries following FDA 510(k) clearance. The milestone marks an advancement in bone graft technology, as OsteoFlo HydroFiber is recognized as a…
Here are four spinal devices that have earned FDA approval, as reported by Becker’s since Jan. 24:
The FDA has cleared Spineart’s Perla TL application for use with eCential Robotics Op.nTM robotic navigation platform. The clearance will combine Spineart and eCential Robotics’ robotic-assisted spine surgery technologies, according to a March 13 news release. The new Perla app…
Here are six key updates from spine and orthopedic companies since March 5. 1. Aurora Spine completed enrollment for its Refine study on lumbar interlaminar fusion. 2. Interim data on Spineart’s Baguera-C cervical disc shows the device meets the threshold…
Medtech company Globus Medical has expanded its spine portfolio by launching its Cohere anterior lumbar interbody fusion spacer and Modulus ALIF blades. The Cohere space is the first porous polyether-ether-ketone interbody spacer for anterior lumbar interbody fusion surgery, according to…
Pramand launched its SpineSeal sealant for spinal dural repair, according to a March 11 news release. SpineSeal is indicated for use as an adjunct to sutured dural repair for a watertight closure. It’s an absorbable polyethylene glycol hydrogel sprayed with…
Vickie Capps joined Orthofix’s board of directors, the medtech company said March 12. Ms. Capps has extensive experience in finance and executive leadership and is on the board for other companies including Amedisys, Janux Therapeutics and Breg. She previously was…