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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.
 
DeviceAccelStim™
Generic NameStimulator, bone growth, non-invasive
Regulation Number890.5870
ApplicantOrthofix US, LLC
3451 Plano Pkwy.
Lewisville, TX 75056
PMA NumberP210035
Supplement NumberS002
Date Received04/12/2024
Decision Date07/11/2024
Reclassified Date05/18/2026
Product Code LOF 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a modification of the previously approved positioning strap utilized to hold the AccelStim transducer in place at the treatment site.
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