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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 NameMOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)
Classification Nameprosthesis, intervertebral disc
ApplicantLDR SPINE USA
PMA NumberP110002
Date Received01/14/2011
Decision Date08/07/2013
Product Code
MJO[ Registered Establishments with MJO ]
Docket Number 13M-0987
Notice Date 08/22/2013
Advisory Committee Orthopedic
Clinical Trials NCT00389597
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the mobi-c® cervical disc prosthesis. 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 level of 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 compared to adjacent levels. The mobi-c® cervical disc prosthesis is implanted using an anterior approach. Patients should have failed at least 6 weeks of conservative treatment or demonstrated progressive signs or symptoms despite nonoperative treatment prior to implantation of the mobi-c® cervical disc prosthesis.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S003 S004 
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