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June 07, 2013
15 Spine Devices Receive FDA 510(k) Clearance in May
The Food and Drug Administration granted 15 spine-related medical device clearances in May.
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Spine and Orthopedic Devices and Implants
Blue Belt Technologies received 510(k) clearance from the U.S. Food and Drug Administration for its STRIDE Unicondylar Knee implant.
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Spine and Orthopedic Devices and Implants
Spinal Elements, based in Carlsbad, Calif., has licensed a portfolio of patents for accessing the lumbar spine and placing implants from a lateral approach.
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Spine and Orthopedic Devices and Implants
Santa Clara, Calif.-based Benvenue Medical completed the yearlong patient follow-up phase in the clinical trial of its Kiva vertebral compression fracture treatment.
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Spine and Orthopedic Devices and Implants
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
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
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
The Food and Drug Administration granted 31 orthopedic- and spine-related clearances in March.
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Spine and Orthopedic Devices and Implants
April 10, 2013
FDA Grants 510(k) Clearance to SterEOS Spine Imaging System
The FDA has granted 510(k) clearance to EOS Imaging for its updated sterEOS 3-D imaging software.
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Spine and Orthopedic Devices and Implants