Data / Medical devices / United States / Xstim Inc.
Xstim Inc.: FDA-registered device maker in Irving, TX, United States, 1 PMA approval
Xstim Inc. is registered with the FDA (registration 3030686063) in Irving, TX, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated February 9, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030686063
- Address
- 1231 Greenway Dr Ste 260, Irving, TX, United States, 75038
- Owner or operator
- Xstim Inc. (10090468)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- April 2, 2024
- Registered through
- 2026
- Brand names listed
- Xstim Spine Fusion Stimulator
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Stimulator, Bone Growth, Non-Invasive | LOF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 9, 2024 | P230025 | Xstim Spine Fusion Stimulator | LOF | 1 | November 12, 2024 | accessdata.fda.gov |
Compare with other makers
Updated November 12, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.