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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.
 
DeviceLDR SPINE MOBI-C CERVICAL DISC PROTHESIS (ONE LEVEL INDICATION)
Classification Nameprosthesis, intervertebral disc
Generic Nameprosthesis, intervertebral disc
Applicant
LDR Spine USA
13785 research boulevard
suite 200
austin, TX 78750
PMA NumberP110002
Supplement NumberS007
Date Received06/27/2014
Decision Date07/23/2014
Product Code
MJO[ Registered Establishments with MJO ]
Advisory Committee Orthopedic
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
ADD BACK-UP EQUIPMENT TO A MANUFACTURING PROCESS.
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