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Displaying items by tag: FDA
The Food and Drug Administration granted 35 orthopedic- and spine-focused 510(k) clearances in April.
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Spine and Orthopedic Devices and Implants
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.
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Spine and Orthopedic Devices and Implants
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.
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Spine
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




