QuadLock Fixation System— 510(k) K253618

Substantially Equivalent

Abanza Tecnomed S.L

FDA 510(k) clearance K253618 for QuadLock Fixation System, Substantially Equivalent on 2026-01-06. Applicant: Abanza Tecnomed S.L.

Clearance details

Applicant: Abanza Tecnomed S.L
Product code: Code MBI
Advisory panel: Orthopedic
Date received: 2025-11-18
Decision date: 2026-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mutilva, ES

Download summary PDF View on FDA.gov ↗

Adverse events under product code MBI

product code MBI

Injury: 3,163
Malfunction: 13,006
Other: 2
Total: 16,171

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.