Tenon Medical, Inc.
Los Gatos, CA, US
TENON MEDICAL, INC. appears in FDA device records in Los Gatos, CA. FDA records list 4 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 4 510(k) clearances for Tenon Medical, Inc. between 2018 and 2026. The busiest year on record is 2018, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2023 | 1 |
| 2025 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K260477 | CATAMARAN™ SI Joint Fusion System | OUR | Substantially Equivalent | |
| K250403 | Catamaran SI Joint Fusion System | OUR | Substantially Equivalent | |
| K231944 | CATAMARAN SI Joint Fusion System | OUR | Substantially Equivalent | |
| K180818 | Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) | OUR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3015425107 | 3015425107 | TENON MEDICAL, INC. | 104 Cooper Court, Los Gatos, CA 95032 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain