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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 (TWO-LEVEL INDICATION)
Classification Nameprosthesis, intervertebral disc
ApplicantLDR SPINE USA INC.
PMA NumberP110009
Date Received03/15/2011
Decision Date08/23/2013
Product Code
MJO[ Registered Establishments with MJO ]
Docket Number 13M-1095
Notice Date 09/10/2013
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 from c3-c7 following discectomy at two contiguous levels for intractable radiculopathy (arm pain and/or a neurological deficit) with or without neck pain, or myelopathy due to 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 mobic® cervical disc prosthesis.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 
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