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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.
 
DeviceSpinal-Stim
Generic NameStimulator, bone growth, non-invasive
ApplicantOrthofix, Inc.
3451 Plano Parkway
Lewisville, TX 75056
PMA NumberP850007
Supplement NumberS035
Date Received07/05/2016
Decision Date12/02/2016
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a new fabric, modifications to the control unit housing, modifications to enlarge the Liquid Crystal Display (LCD), a change from a three-cell lithium-ion battery to a single lithium-ion battery, a change in the Printed Circuit Assembly (PCA), a modification to include a smaller power supply, updates to device firmware, a new iOS mobile application, and minor updates to labeling. The modified devices will be marketed under the trade names Spinal-Stim Model 5212 and Cervical-Stim Model 5505.
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