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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSimplify® Cervical Artificial Disc
Generic Nameprosthesis, intervertebral disc
Applicant
Simplify Medical, Inc.
685 north pastoria avenue
sunnyvale, CA 94085
PMA NumberP200022
Date Received03/25/2020
Decision Date09/18/2020
Product Code MJO 
Docket Number 20M-1986
Notice Date 09/21/2020
Advisory Committee Orthopedic
Clinical Trials NCT02667067
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for Simplify® Cervical Artificial Disc that is indicated for use in skeletally mature patients for reconstruction of the disc at one level from C3-C7 following single-level discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to a single-level abnormality localized to the level of the disc space and manifested by at least one of the following conditions confirmed by radiographic imaging (e.g., X-rays, computed tomography (CT), magnetic resonance imaging (MRI)): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. Patients receiving Simplify® Cervical Artificial Disc should have failed at least six weeks of non-operative treatment or have the presence of progressive symptoms (e.g., numbness or tingling) prior to implantation. Simplify® Cervical Artificial Disc is implanted via an open anterior approach.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S004 S002 
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