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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
Generic NameProsthesis, intervertebral disc
ApplicantHighridge Medical, LLC
10225 Westmoor Dr.
Westminister, CO 80021
PMA NumberP110002
Supplement NumberS009
Date Received12/08/2014
Decision Date02/05/2015
Product Code MJO 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MODIFICATIONS MADE TO THE MOBI-C UNIVERSAL INSERTERINSTRUMENT, WHICH INCLUDED ADDITION OF MATERIAL TO INCREASE THE INNER DIAMETER AND A CHANGE TO THE LASER MARKING AND PASSIVATION PROCESS.
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