161. Cervical Disc Replacement Using a PEEK-on-Ceramic Implant: Prospective Data from Seven Sites Participating in an FDA IDE Trial for Single-level Surgery
Richard D. Guyer, MD1; Domagoj Coric, MD2; Cameron N. Carmody, MD3; Rick C. Sasso, MD4; Michael J. Musacchio, MD5; Hyun W. Bae, MD6; Donna D. Ohnmeiss, PhD7
1Center for Disc Replacement at Texas Back Institute, Plano, TX, US; 2Carolina ...
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 ...
