FDA 510(k)

QuadLock Fixation System

K-Number: K253618 · 2026-01-06

Decision Date2026-01-06

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

QuadLock Fixation System is a medical device manufactured by Abanza Tecnomed S.L. It received FDA 510(k) clearance on 2026-01-06 under approval number K253618. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QuadLock Fixation System?

QuadLock Fixation System is a medical device that received FDA 510(k) clearance on 2026-01-06. It is manufactured by Abanza Tecnomed S.L. The 510(k) number is K253618.

When was QuadLock Fixation System approved by the FDA?

QuadLock Fixation System received FDA 510(k) clearance on 2026-01-06, under approval number K253618.

What company makes QuadLock Fixation System?

QuadLock Fixation System is manufactured by Abanza Tecnomed S.L.

What is the FDA product code for QuadLock Fixation System?

The FDA product code for QuadLock Fixation System is MBI.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07245719 Stryker Universal Midface and Upper-Face Fixation System: A Retrospective Post Market Follow Up COMPLETED NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT07079774 TrueLok Elevate PMCF Study RECRUITING

Other Devices by Abanza Tecnomed S.L

K212197WasherCap Fixation System K250238WasherCap Fixation System K243712WasherCap Mini Fixation System (Model 45)

Related Devices (Code: MBI)

K163034SUTUREFIX Curved Suture AnchorSmith and Nephew, Inc. K162198GFS UltimateParcus Medical, LLC K162386KATOR Suture AnchorKator, LLC K161033AFX Femoral Implant With InserterCayenne Medical, Inc. K160996Dunamis Suture Anchor PEEK 3.0mm, 3.5mm, 4.5mm, 5.5mm, 6.5mmDunamis, LLC K161001MILAGRO ADVANCE PEEK Interference ScrewMedos International SARL

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.