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Displaying items by tag: FDA
The Food and Drug Administration granted 14 spine device-related clearances in April, according to an FDA report.
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Spine and Orthopedic Devices and Implants
The Food and Drug Administration granted 33 orthopedic- and spine-related device clearances in April.
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Spine and Orthopedic Devices and Implants
April 16, 2012
17 Spine Devices Receive FDA 510(k) Clearance in March
The Food and Drug Administration granted 17 spine-related medical device clearances in March.
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Spine and Orthopedic Devices and Implants
Biotechnology company Arteriocyte has received approval from the Food and Drug Administration to initiate a Phase I clinical trial with its Magellan MAR01 technology for treating compartment syndrome in extremity trauma patients.
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Spine and Orthopedic Devices and Implants
The Food and Drug Administration granted 38 orthopedic- and spine-related medical device clearances in March.
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Spine and Orthopedic Devices and Implants
The Food and Drug Administration has issued Lucero Medical a letter of warning related to its spinal fusion device Enduramesh.
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Spine and Orthopedic Devices and Implants
The Food and Drug Administration will hold a two-day expert review on metal-on-metal hip replacements that may result in new standards for the device, according to a New York Times report.
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Spine and Orthopedic Devices and Implants
Two Murrieta, Calif.-based medical device companies have received warnings from the Food and Drug Administration for a lack of quality control over the manufacturing or assembling process.
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Spine and Orthopedic Devices and Implants
March 28, 2012
FDA Publishes Guidance for Pre-Market Approvals
The Food and Drug Administration published guidance for medical device manufacturers that describes how the benefits and risks of certain medical devices are considered during the pre-market review.
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Spine and Orthopedic Devices and Implants
Ascendx Spine announced it received FDA 510(k) clearance for its Acu-Cut Vertebral Augmentation System for treating vertebral compression fractures.
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Spine and Orthopedic Devices and Implants




