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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMOBI-C CERVICAL DISC PROSTHESIS (TWO LEVELS)
Generic Nameprosthesis, intervertebral disc
ApplicantZimmer Biomet Spine, Inc.
10225 westmoor drive
westminster, CO 80021
PMA NumberP110009
Supplement NumberS005
Date Received03/28/2014
Decision Date07/15/2014
Product Code MJO 
Advisory Committee Orthopedic
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.
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