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Precision Spine® Receives FDA 510(K) Clearance for the Dakota ACDF™ Standalone System
February 4, 2021 GMT
PARSIPPANY, N.J. (BUSINESS WIRE) Feb 4, 2021
Precision Spine, Inc., a medical device company dedicated to Made-in-the-USA manufacturing, announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Dakota ACDF™ Standalone System in the treatment of degenerative disc disease (DDD). The Dakota ACDF system features a titanium plate polyetheretherketone (PEEK) cage with cortical cancellous screws for maximum support and a generous cavity for autogenous bone graft to help facilitate fusion.