AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws— 510(k) K141680

Substantially Equivalent

Auxein Medical

FDA 510(k) clearance K141680 for AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws, Substantially Equivalent on 2015-06-30. Applicant: Auxein Medical.

Clearance details

Applicant: Auxein Medical
Product code: Code HRS
Advisory panel: Orthopedic
Date received: 2014-06-23
Decision date: 2015-06-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Delhi, 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.