AccelStimTM Bone Growth Stimulator

FDA Premarket Approval P210035

Pre-market Approval Supplement Details

DeviceAccelStimTM Bone Growth Stimulator
Generic NameStimulator, Bone Growth, Non-invasive
ApplicantOrthofix US LLC3451 Plano Parkwaylewisville, TX 75056 PMA NumberP210035 Date Received10/13/2021 Decision Date05/03/2022 Product Code LOF  Advisory Committee Orthopedic Expedited Review Granted? No
Date Received2021-10-13
Decision Date2022-05-03
PMAP210035
SupplementS
Product CodeLOF 
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination ProductNo
Applicant AddressOrthofix US LLC
3451 Plano Parkway
lewisville, TX 75056 PMA NumberP210035 Date Received10/13/2021 Decision Date05/03/2022 Product Code LOF  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 LabelingLabeling
Supplements:  

Supplemental Filings

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Supplement NumberDateSupplement Type
P210035Original Filing

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