AccelStimTM Bone Growth Stimulator

FDA Premarket Approval P210035

Pre-market Approval Supplement Details

• Device: AccelStimTM Bone Growth Stimulator
• Generic Name: Stimulator, Bone Growth, Non-invasive
• Applicant: Orthofix 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 Received: 2021-10-13
• Decision Date: 2022-05-03
• PMA: P210035
• Supplement: S
• Product Code: LOF
• Advisory Committee: Orthopedic
• Expedited Review: No
• Combination Product: No
• Applicant Address: Orthofix 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 Number	Date	Supplement Type
P210035		Original Filing

NIH GUDID Devices

Device ID	PMA	Supp
08050040997213	P210035	000
08050040997329	P210035	000
08050040997312	P210035	000
08050040997305	P210035	000
08050040997299	P210035	000
08050040997336	P210035	000