Sanford Health Clinic Physician Receives FDA 510(k) Market Clearance For Spinal Implant

Wilson Asfora, MD, of Sanford Clinic Neurosurgery and Spine in Sioux Falls, S.D., received U.S. Food and Drug Administration 510(k) market clearance for a spinal implant to be used as a lumbar intervertebral body fusion device, according to a news release from Sanford Health.

Advertisement

The Asfora Bullet Cage is designed for use in posterior lumbar interbody fusion surgeries to treat degenerative disc disease, according to the release. Dr. Asfora noted in clinical experience to date that the implant has a 98 percent rate of interbody fusion of one or two levels using locally harvested bone without unexpected complications or the use of pedicle screws or bone morphogenic protein.

The Asfora Bullet Cage will be manufactured and sold by Medical Designs, LLC, a company owned by Dr. Asfora and based in Sioux Falls.

Read the Sanford Health release about the FDA 510(k) market approval of the Asfora Bullet Cage.

At the Becker's 23rd Annual Spine, Orthopedic and Pain Management-Driven ASC + The Future of Spine Conference, taking place June 18–20 in Chicago, spine surgeons, orthopedic leaders and ASC executives will come together to explore minimally invasive techniques, ASC growth strategies and innovations shaping the future of outpatient spine care. Apply for complimentary registration now.

Advertisement

Next Up in Uncategorized

Advertisement

Comments are closed.