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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.
 
DeviceMOBI-C CERVICAL DISC PROSTHESIS FOR USE AT ONE OR TWO LEVELS
Classification Nameprosthesis, intervertebral disc
Generic Nameprosthesis, intervertebral disc
Applicant
LDR SPINE USA INC.
13785 research boulevard
suite 200
austin, TX 78750
PMA NumberP110009
Supplement NumberS004
Date Received01/24/2014
Decision Date02/21/2014
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 
Supplier change.
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