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Surgical GloveThe Food and Drug Administration granted 35 orthopedic- and spine-focused 510(k) clearances in April.
New York City-based Paradigm Spine launched its coflex Solution website, a patient-centered site with information on lumbar spinal stenosis and both surgical and non-surgical treatment options.
On May 7, Behrooz Akbarnia, MD, led a team of surgeons at Rady Children's Hospital-San Diego in performing two pediatric surgeries with Ellipse Technologies' MAGnetic Expansion Control System.
Published in Spine
Gainesville, Fla.-based Exactech received FDA clearance for the Gibralt Occipital Spine System, which features occipital plates and 360 degree articulating rods.
Miamisburg, Ohio-based X-Spine received FDA clearance for its Zygafix Facet Fusion System for fusion and stabilization of the facet joint.
Warsaw, Ind.-based DePuy Orthopaedics received FDA pre-market supplement approval for its CERAMAX total hip system and BIOLOX delta ceramic-on-ceramic 36mm large femoral head.
Dayton, Ohio-based NovoSource received FDA clearance for its NovoKnee total knee replacement system, according to the Dayton Business Journal.
Austin, Texas-based Wenzel Spine has launched its newest spine implant, the VariLift-C Stand-Alone Zero-Profile Expandable Cervical Interbody Fusion Device, three months after receiving FDA market clearance.
The FDA has released an update to its plan to monitor medical devices, which includes the use of electronic health records and mobile applications.
Shelton, Conn.-based Spine Wave received FDA 510(k) clearance for its StaXx IB System, an intervertebral body fusion device.
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