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Device | AccelStimTM Bone Growth Stimulator |
Generic Name | Stimulator, bone growth, non-invasive |
Applicant | Orthofix US LLC 3451 Plano Parkway Lewisville, TX 75056 |
PMA Number | P210035 |
Date Received | 10/13/2021 |
Decision Date | 05/03/2022 |
Product Code |
LOF |
Docket Number | 22M-0751 |
Notice Date | 05/06/2022 |
Advisory Committee |
Orthopedic |
Expedited Review Granted? | No |
Combination Product | No |
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 Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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