Data / Medical devices / United States / Tenon Medical, Inc.
Tenon Medical, Inc.: FDA-registered device maker in Los Gatos, CA, United States, 3 510(k) clearances
Tenon Medical, Inc. is registered with the FDA (registration 3015425107) in Los Gatos, CA, United States. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated July 29, 2025. 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
- 3015425107
- Address
- 104 Cooper Court, Los Gatos, CA, United States, 95032
- Owner or operator
- Tenon Medical, Inc. (10059873)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- March 3, 2019
- Registered through
- 2026
- Brand names listed
- Catamaran Sacroiliac Joint System (CAT SIJ Joint System), SImmetry SI Joint Fusion System, SImmetry+ SI Joint Fusion System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Sacroiliac Joint Fixation | OUR | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 29, 2025 | K250647 | SImmetry+ System | OUR | Substantially Equivalent | Sivantage | accessdata.fda.gov |
| June 13, 2018 | K180818 | Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) | OUR | Substantially Equivalent | Tenon Medical, Inc. | accessdata.fda.gov |
| August 5, 2015 | K151818 | SImmetry Sacroiliac Joint Fusion System | OUR | Substantially Equivalent | Zyga Technology, Inc. | accessdata.fda.gov |
Compare with other makers
Updated July 29, 2025. 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.