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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 NumberS002
Date Received05/13/2009
Decision Date07/10/2009
Product Code
LOF[ Registered Establishments with LOF ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the relocation and change of the charge management controller and the replacement of the charger unit. The device, as modified, will be marketed under the trade name cervical-stim cervical fusion system and is indicated as an adjunct to cervical fusion surgery in patients at high risk for non-fusion.
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