Press Releases

Press Releases

Simplify Medical Completes PMA Submission for 2-Level Simplify Disc IDE Study

Builds on recent 1-Level PMA Approval

SUNNYVALE, Calif., Oct. 29, 2020 (GLOBE NEWSWIRE) -- Simplify Medical, Inc., maker of the Simplify® Cervical Artificial Disc, announced today the completion of the Pre-Market Approval (PMA) submission for the 2-level Simplify Disc IDE Study to the U.S. Food and Drug Administration (FDA). The Simplify Disc is designed for MRI compatibility, physiologic ...

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Press Releases

Simplify Medical Receives FDA Approval for 1-Level Simplify Disc PMA

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) ...

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Press Releases

Simplify Medical Completes PMA Submission for 1-Level Simplify Disc IDE Study

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 ...

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