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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMOBI-C CERVICAL DISC PROSTHESIS (ONE-LEVEL INDICATION)
Generic Nameprosthesis, intervertebral disc
ApplicantZimmer Biomet Spine, Inc.
10225 westmoor drive
westminster, CO 80021
PMA NumberP110002
Date Received01/14/2011
Decision Date08/07/2013
Product Code MJO 
Docket Number 13M-0987
Notice Date 08/22/2013
Advisory Committee Orthopedic
Clinical TrialsNCT00389597
Expedited Review Granted? No
Combination ProductNo
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 INTRACTABLERADICULOPATHY (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 ORDEMONSTRATED PROGRESSIVE SIGNS OR SYMPTOMS DESPITE NONOPERATIVE TREATMENT PRIOR TO IMPLANTATION OF THE MOBI-C® CERVICAL DISC PROSTHESIS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S015 S016 S018 S019  S004 S012 S013 S020 S021 S022 S023 
S024 S026 S029 S030 S031 S032 S003 S010 S011 S008 S009 S007 
S005 S006 S001 S002 
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