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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.
 
DeviceCervicalStim
Generic NameStimulator, bone growth, non-invasive
ApplicantOrthofix, Inc.
3451 Plano Parkway
Lewisville, TX 75056
PMA NumberP030034
Supplement NumberS014
Date Received04/15/2019
Decision Date06/18/2019
Product Code LOF 
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 software and firmware updates to the SpinalStim. CervicalStim, and PhysioStim devices. The updates made are identical to each devices, and include modifications to the mobile medical phone application
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