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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSimplify Cervical Artificial Disc
Generic NameProsthesis, intervertebral disc
ApplicantGlobus Medical, Inc.
2560 General Armistead Ave.
Audubon, PA 19403
PMA NumberP200022
Supplement NumberS003
Date Received10/27/2020
Decision Date04/01/2021
Product Code MJO 
Docket Number 21M-0355
Notice Date 04/12/2021
Advisory Committee Orthopedic
Clinical TrialsNCT03123549
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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 or two contiguous levels from C3-C7 following discectomy for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to abnormality localized to 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 demonstrated progressive signs or symptoms despite non-operative treatment prior to implantation. Simplify® Cervical Artificial Disc is implanted via an open anterior approach.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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