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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
Regulation Number890.5870
ApplicantOrthofix, Inc.
3451 Plano Pkwy.
Lewisville, TX 75056
PMA NumberP030034
Supplement NumberS015
Date Received09/16/2019
Decision Date10/08/2019
Reclassified Date05/18/2026
Product Code LOF 
Advisory Committee Orthopedic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Modify the manufacturing process for sewing the garment assembly for the Orthofix SpinalStim Model 5212 and modify the manufacturing process to cut, split, and strip the ribbon cable for the Orthofix CervicalStim Model 5505 and Orthofix PhysioStim Models 53XX.
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