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Displaying items by tag: FDA
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.
The amount of failed robotic surgeries has tripled from 2008 to 2012 and the FDA intends to investigate and determine the cause, according to a Kaiser Health News report.
Published in Spine
HHS and Federal Communications Commission have selected members for a new workgroup that will promote innovation in health information technology, including mobile medical applications, and identify ways to improve patient safety through health IT.
Atlanta-based MedShape received FDA 510(k) clearance for its Eclipse Soft Tissue Anchor, a shape memory fixation device to attach tendon, ligament and soft tissue to bone.
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