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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.
 
Trade NameCERVICAL-STIM
Classification Namestimulator, bone growth, non-invasive
ApplicantORTHOFIX, INC.
PMA NumberP030034
Supplement NumberS004
Date Received01/21/2010
Decision Date01/12/2011
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located in lewisville, texas.
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