Data / Medical devices / Israel / Augmedics Ltd.
Augmedics Ltd.: FDA-registered device maker in Yokneam Illit Northern, Israel, 7 510(k) clearances
Augmedics Ltd. is registered with the FDA (registration 3016571711) in Yokneam Illit Northern, Israel. It lists 1 device type. The FDA files 7 510(k) clearances under its listings, the newest dated July 31, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3016571711
- Address
- 2 Ha-Otsma St, Yokneam Illit Northern, Israel, 2069205
- 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 |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| April 14, 2025 | 96686 | Class II | Ongoing | Augmedics Perc Pin Adaptor, Model/Catalog Number AMCH07200, a component of the xvision Spine (XVS) system, an image-guided navigation system that is designed to assist surgeons in placing pedicle screws accurately, durin | The perc pin adaptor AMCH07200 tightening knob was found to be inconvenient to the user and the tightening markings found to be improperly placed. | 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.