Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System)— 510(k) K180818

Substantially Equivalent

Tenon Medical, Inc.

FDA 510(k) clearance K180818 for Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System), Substantially Equivalent on 2018-06-13. Applicant: Tenon Medical, Inc..

Clearance details

Applicant: Tenon Medical, Inc.
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2018-03-29
Decision date: 2018-06-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Ramon, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OUR

product code OUR

Death: 3
Injury: 347
Total: 350

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.