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The Food and Drug Administration granted 40 orthopedic- and spine-related clearances in May.
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Spine and Orthopedic Devices and Implants
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
The FDA has accepted BioMarin Pharmaceutical's biologics license application for Vimizim, an enzyme therapy that could be used to treat Mucopolysaccharidosis Type IVA or Morquio A Syndrome, according to Pipeline Review.
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Spine and Orthopedic Devices and Implants
The Orthopedic and Rehabilitation panel for the U.S. Food and Drug Administration recommended changes to the pedicle screw's classification when it's used for treating degenerative disc disease and spondylolisthesis, according to a Medscape report.
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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
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




