Xstim Spine Fusion Stimulator
FDA premarket approval P230025 · decided 2024-02-09
Approval details
- PMA number
- P230025
- Trade name
- Xstim Spine Fusion Stimulator
- Generic name
- Stimulator, bone growth, non-invasive
- Applicant
- Xstim, Inc.
- Date received
- 2023-08-15
- Decision date
- 2024-02-09
- Days to decision
- 178 days
- Decision code
- APPR
- Product code
- LOF
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Irving, TX
- Statement
- The Xstim Spine Fusion Stimulator is a non-invasive bone growth stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. The device is for prescription use only and is intended for single patient use in adult patients only.
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