Simplify Disc overall success rate of 93.0% was superior to the ACDF control
SUNNYVALE, Calif., Sept. 21, 2020 (GLOBE NEWSWIRE) -- Simplify Medical, a privately-held company focused on cervical spinal disc arthroplasty and developer of the Simplify®cervical artificial disc, today announced U.S. Food and Drug Administration (FDA) Approval for the Simplify Disc Pre-Market Application (PMA) ...
FDA Determined PMA is Complete and is Commencing Filing Review
Sunnyvale, CA – April 21, 2020 – Simplify Medical Pty Ltd., maker of the Simplify® Cervical Artificial Disc, announced today the completion of the Pre-Market Approval (PMA) submission for the 1-level Simplify Disc IDE Study to the U.S. Food and Drug Administration (FDA). The Simplify ...
Clinical Outcomes of a PEEK-on-Ceramic Total Disc Replacement: Data from Three Sites Participating in the Two-Level Cervical FDA IDE Trial
Presented at the International Society for the Advancement of Spine Surgery (ISASS), February 28, 2020
Background:
To date, good results have been reported for a variety of cervical total disc replacements (TDRs). These devices ...
Comparison of MRI Artifacts of Cervical Artificial Discs
Pierce Nunley, MD1; Domagoj Coric, MD2; Olivier Clerk-Lamalice, MD-MSc, FRCPC, FIPP3; Kelly Frank, MS1; Marcus Stone, PhD1
1 Spine Institute of Louisiana; 2 Carolina Neurosurgery & Spine Associates; 3 University of Alberta
Presented at the International Society for the Advancement of Spine Surgery (ISASS), February ...
