AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating System— 510(k) K202489

Substantially Equivalent

Advanced Orthopaedic Solutions, Inc.

FDA 510(k) clearance K202489 for AOS Fibonacci Lower Extremity Plating System AOS Proximal Tibia Plating System, Substantially Equivalent on 2020-10-26. Applicant: Advanced Orthopaedic Solutions, Inc..

Clearance details

Applicant: Advanced Orthopaedic Solutions, Inc.
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2020-08-31
Decision date: 2020-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code HRS

product code HRS

Death: 27
Injury: 10,340
Malfunction: 3,328
Total: 13,695

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.