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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
ApplicantZimmer Biomet Spine, Inc.
10225 westmoor drive
westminster, CO 80021
PMA NumberP110009
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
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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