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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceManaFuse
Generic NameStimulator, bone growth, non-invasive
ApplicantManamed, Inc.
5240 W. Charleston Blvd.
Las Vegas, NV 89146
PMA NumberP210016
Date Received04/26/2021
Decision Date01/17/2025
Product Code LOF 
Docket Number 25M-0285
Notice Date 01/31/2025
Advisory Committee Orthopedic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The ManaFuse system is indicated for the non-invasive treatment of established non-unions excluding skull and vertebra, and for accelerating the time to a healed fracture for fresh, closed, posteriorly displaced distal radius fractures and fresh, closed or Grade I open tibial diaphysis fractures in skeletally mature adult individuals when these fractures are orthopedically managed by closed reduction and cast immobilization.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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