CATAMARAN SI Joint Fusion System— 510(k) K260477
Substantially EquivalentTenon Medical
FDA 510(k) clearance K260477 for CATAMARAN SI Joint Fusion System, Substantially Equivalent on 2026-04-08. Applicant: Tenon Medical. Device class: 2.
Summary
Tenon Medical's CATAMARAN SI Joint Fusion System is filed under product code OUR (Sacroiliac Joint Fixation).
Class II, 21 CFR 888.3040. Orthopedic is both the classification panel and the review panel. It came in as a Traditional 510(k).
Tenon Medical filed from Los Gatos, California. The record shows 55 calendar days from receipt to decision (February 12 to April 8, 2026).
Clearance details
- Applicant
- Tenon Medical
- Product code
- Product code OUR
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Los Gatos, CA, US
Recent devices under product code OUR
view allMore clearances from Tenon Medical
view allAdverse events under product code OUR
product code OUR- Death
- 3
- Injury
- 347
- Total
- 350
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.