Data / Medical devices / United States / Augmedics Ltd.
Augmedics Ltd.: FDA-registered device maker in Elgin, IL, United States, 7 510(k) clearances
Augmedics Ltd. is registered with the FDA (registration 3016566146) in Elgin, IL, United States. It lists 1 device type. The FDA files 7 510(k) clearances under its listings, the newest dated July 31, 2026. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3016566146
- Address
- 2580 Northwest Parkway, Elgin, IL, United States, 60124
- Owner or operator
- Augmedics Ltd. (10062650)
- Roles
- Manufacturer
- First device listed
- February 26, 2020
- Registered through
- 2026
- Brand names listed
- XVision Spine System (XVS)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Augmented Reality | SBF | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 31, 2026 | K261854 | xvision Spine system | SBF | Substantially Equivalent | Augmedics, Ltd. | accessdata.fda.gov |
| October 3, 2025 | K251639 | xvision Spine system | SBF | Substantially Equivalent | Augmedics, Ltd. | accessdata.fda.gov |
| March 13, 2025 | K250255 | xvision Spine system | SBF | Substantially Equivalent | Augmedics, Ltd. | accessdata.fda.gov |
| October 16, 2024 | K241481 | xvision Spine System | SBF | Substantially Equivalent | Augmedics, Ltd. | accessdata.fda.gov |
| November 17, 2022 | K220905 | xvision Spine System | SBF | Substantially Equivalent | Augmedics, Ltd. | accessdata.fda.gov |
| July 19, 2021 | K211188 | xvision Spine system (XVS) | SBF | Substantially Equivalent | Augmedics, Ltd. | accessdata.fda.gov |
| December 20, 2019 | K190929 | xvision Spine system (XVS) | SBF | Substantially Equivalent | Augmedics, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated July 31, 2026. 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.