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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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DeviceAccelStimTM Bone Growth Stimulator
Generic NameStimulator, bone growth, non-invasive
ApplicantOrthofix US LLC
3451 Plano Parkway
Lewisville, TX 75056
PMA NumberP210035
Date Received10/13/2021
Decision Date05/03/2022
Product Code LOF 
Docket Number 22M-0751
Notice Date 05/06/2022
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for the AccelStim Ultrasound Bone Growth Stimulator, a non-invasive Low-Intensity Pulsed Ultrasound (LIPUS) device intended to aid fracture healing. The device is Rx only, and intended for single patient use in adult patients only.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness