Simplify® Cervical Artificial Disc

FDA Premarket Approval P200022

Pre-market Approval Supplement Details

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.

DeviceSimplify® Cervical Artificial Disc
Generic NameProsthesis, Intervertebral Disc
ApplicantSimplify Medical, Inc.
Date Received2020-03-25
Decision Date2020-09-18
Product CodeMJO 
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address Simplify Medical, Inc. 685 North Pastoria Avenue sunnyvale, CA 94085

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Supplement NumberDateSupplement Type
P200022Original Filing

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