Advanced Research Medical Trident SI Screw System— 510(k) K203373

Substantially Equivalent

Advanced Research Medical, LLC

FDA 510(k) clearance K203373 for Advanced Research Medical Trident SI Screw System, Substantially Equivalent on 2021-01-22. Applicant: Advanced Research Medical, LLC.

Clearance details

Applicant: Advanced Research Medical, LLC
Product code: Code OUR
Advisory panel: Orthopedic
Date received: 2020-11-16
Decision date: 2021-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Burnsville, MN, 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.