AccelStimTM Bone Growth Stimulator
FDA premarket approval P210035 · decided 2022-05-03
Approval details
- PMA number
- P210035
- Trade name
- AccelStimTM Bone Growth Stimulator
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix US, LLC
- Date received
- 2021-10-13
- Decision date
- 2022-05-03
- Days to decision
- 202 days
- Decision code
- APRL
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Firebird SI Navigation System (K252088) | Orthofix US, LLC | 2025-10-31 |
| OFIX MIS App (K230252) | Orthofix US, LLC | 2023-09-26 |
| 3° Anterior Cervical Plating System, Reliant Anterior Cervical Plating System, Unity Lumbosacral Fixation System, Hallmark Anterior Plate System, NewBridge Laminoplasty Fixation System, CETRA Anterior Cervical Plate System (K211712) | Orthofix US, LLC | 2022-02-11 |
| FORZA XP Expandable Spacer System (K213951) | Orthofix US, LLC | 2022-01-05 |