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Spinal Implant Developed by Sanford Clinic Neurosurgeon Receives FDA 510(k) Market Clearance as a Lumbar Intervertebral Body Fusion Device
Date:8/27/2009

Sanford Health, a comprehensive health care provider in the Upper Midwest, announced today a spinal implant developed by Sanford Clinic Neurosurgeon, Wilson Asfora, MD, Sanford Clinic Neurosurgery & Spine, has received United States Food and Drug Administration (FDA) 510(k) market clearance as a lumbar intervertebral body fusion device.

Sioux Falls, SD (Vocus) August 27, 2009 -- Sanford Health, a comprehensive health care provider in the Upper Midwest, announced today a spinal implant developed by Sanford Clinic Neurosurgeon, Wilson Asfora, MD, Sanford Clinic Neurosurgery & Spine, has received United States Food and Drug Administration (FDA) 510(k) market clearance as a lumbar intervertebral body fusion device. On August 14, 2009, the FDA gave 510(k) clearance to the Asfora Bullet Cage, a product which is designed for use in posterior lumbar interbody fusion surgeries to treat degenerative disc disease. The Asfora Bullet Cage will be manufactured and sold by Medical Designs, LLC, a Sioux Falls company owned by Dr. Asfora.

"We congratulate Dr. Asfora on the FDA approval of his spinal implant," said Dave Link, Sanford Health Executive Vice President. "At Sanford Health, our goal is to foster an environment which supports the efforts of our physicians to develop innovative solutions for the global health care market."

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