AOS Small Fragment Plating System— 510(k) K161913

Substantially Equivalent

Advanced Orthopaedic Solutions, Inc. (Aos)

FDA 510(k) clearance K161913 for AOS Small Fragment Plating System, Substantially Equivalent on 2016-11-04. Applicant: Advanced Orthopaedic Solutions, Inc. (Aos).

Clearance details

Applicant: Advanced Orthopaedic Solutions, Inc. (Aos)
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2016-07-12
Decision date: 2016-11-04
Decision: Substantially Equivalent
Clearance type: Special
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.