| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | Xstim Spine Fusion Stimulator |
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| Generic Name | Stimulator, bone growth, non-invasive |
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| Regulation Number | 890.5870 |
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| Applicant | Xstim, Inc.
1231 Greenway Dr.
Suite 260
Irving, TX 75038 |
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| PMA Number | P230025 |
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| Date Received | 08/15/2023 |
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| Decision Date | 02/09/2024 |
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| Product Code |
LOF |
| Docket Number | 24M-0782 |
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| Notice Date | 02/21/2024 |
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| Advisory Committee |
Orthopedic |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order 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. |
| Approval Order | Approval Order |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Supplements: |
S001 |
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