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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMOBI-C CERVICAL DISC PROSTHESIS (ONE LEVEL)
Classification Nameprosthesis, intervertebral disc
ApplicantLDR SPINE USA
PMA NumberP110002
Supplement NumberS005
Date Received03/28/2014
Decision Date07/15/2014
Product Code
MJO[ Registered Establishments with MJO ]
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the post-approval study protocol.
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