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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSECURE-C ARTIFICIAL CERVICAL DISC
Classification Nameprosthesis, intervertebral disc
ApplicantGLOBUS MEDICAL INC.
PMA NumberP100003
Date Received01/29/2010
Decision Date09/28/2012
Product Code
MJO[ Registered Establishments with MJO ]
Docket Number 12M-1039
Notice Date 10/02/2012
Advisory Committee Orthopedic
Clinical Trials NCT00882661
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the secure-c artificial cervical disc. This device is indicated 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 disc space and at least one of the following conditions confirmed by radiographic imaging (ct, mri, x-rays): herniated nucleus pulposus, spondylosis (defined by the presence of osteophytes), and/or visible loss of disc height as compared to adjacent levels. The secure-c cervical artificial disc is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment prior to implantation of the secure-c cervical artificial disc.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 
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