XLO Brand of Locking Distal Humerus Plating System— 510(k) K233873

Substantially Equivalent

Ortho Life Systems Private Limited

FDA 510(k) clearance K233873 for XLO Brand of Locking Distal Humerus Plating System, Substantially Equivalent on 2024-04-26. Applicant: Ortho Life Systems Private Limited.

Clearance details

Applicant: Ortho Life Systems Private Limited
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2023-12-07
Decision date: 2024-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Okhla, IN

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.