T-Rex Standalone ALIF— 510(k) K170855

Substantially Equivalent

Siats, LLC

FDA 510(k) clearance K170855 for T-Rex Standalone ALIF, Substantially Equivalent on 2017-09-07. Applicant: Siats, LLC.

Clearance details

Applicant: Siats, LLC
Product code: Code OVD
Advisory panel: Orthopedic
Date received: 2017-03-22
Decision date: 2017-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tulsa, OK, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code OVD

product code OVD

Death: 5
Injury: 495
Total: 500

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.