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Device | Simplify Cervical Artificial Disc |
Generic Name | Prosthesis, intervertebral disc |
Applicant | NuVasive, Inc. 7475 Lusk Boulevard San Diego, CA 92121 |
PMA Number | P200022 |
Supplement Number | S003 |
Date Received | 10/27/2020 |
Decision Date | 04/01/2021 |
Product Code |
MJO |
Docket Number | 21M-0355 |
Notice Date | 04/12/2021 |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT03123549
|
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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 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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |