AccelStim
FDA premarket approval P210035/S002 · decided 2024-07-11
Approval details
- PMA number
- P210035
- Supplement
- S002
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AccelStim
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Orthofix US, LLC
- Date received
- 2024-04-12
- Decision date
- 2024-07-11
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Lewisville, TX
- Statement
- Approval for a modification of the previously approved positioning strap utilized to hold the AccelStim transducer in place at the treatment site.
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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 |