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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.
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Spine and Orthopedic Devices and Implants
Miamisburg, Ohio-based X-Spine received FDA clearance for its Zygafix Facet Fusion System for fusion and stabilization of the facet joint.
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Spine and Orthopedic Devices and Implants
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.
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Spine and Orthopedic Devices and Implants
Dayton, Ohio-based NovoSource received FDA clearance for its NovoKnee total knee replacement system, according to the Dayton Business Journal.
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Spine and Orthopedic Devices and Implants
April 30, 2013
Wenzel Spine Launches Cervical Interbody Fusion Implant
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.
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Spine and Orthopedic Devices and Implants
April 29, 2013
FDA to Use EHRs, Mobile App to Monitor Medical Devices
The FDA has released an update to its plan to monitor medical devices, which includes the use of electronic health records and mobile applications.
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Health Information Technology
Shelton, Conn.-based Spine Wave received FDA 510(k) clearance for its StaXx IB System, an intervertebral body fusion device.
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Spine and Orthopedic Devices and Implants
April 25, 2013
FDA to Investigate Rising Rate of Failed Robotic Surgeries
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.
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Spine
April 22, 2013
HHS, FCC Form New Health IT Workgroup for Patient Safety
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.
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Health Information Technology
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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Spine and Orthopedic Devices and Implants




