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FDA 510(k)

MONDRIAN ALIF Cage with Supplementary Fixation Plate

K-Number: K213641 · 2022-09-15

ApplicantCtl Medical Corporation
Decision Date2022-09-15
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONDRIAN ALIF Cage with Supplementary Fixation Plate is a medical device manufactured by Ctl Medical Corporation. It received FDA 510(k) clearance on 2022-09-15 under approval number K213641. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONDRIAN ALIF Cage with Supplementary Fixation Plate?

MONDRIAN ALIF Cage with Supplementary Fixation Plate is a medical device that received FDA 510(k) clearance on 2022-09-15. It is manufactured by Ctl Medical Corporation. The 510(k) number is K213641.

When was MONDRIAN ALIF Cage with Supplementary Fixation Plate approved by the FDA?

MONDRIAN ALIF Cage with Supplementary Fixation Plate received FDA 510(k) clearance on 2022-09-15, under approval number K213641.

What company makes MONDRIAN ALIF Cage with Supplementary Fixation Plate?

MONDRIAN ALIF Cage with Supplementary Fixation Plate is manufactured by Ctl Medical Corporation.

What is the FDA product code for MONDRIAN ALIF Cage with Supplementary Fixation Plate?

The FDA product code for MONDRIAN ALIF Cage with Supplementary Fixation Plate is MAX.

Related Clinical Trials

NCT07608380 Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures ENROLLING_BY_INVITATION NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07574554 Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation ACTIVE_NOT_RECRUITING NCT06409559 Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws RECRUITING NCT06660186 Sternal Plating High Risk RECRUITING NCT07520227 Comparative Evaluation of 3D-printed (PEEK) Plates Versus Titanium 3D Plate for Fracture Fixation at the Mandibular Angle COMPLETED

Other Devices by Ctl Medical Corporation

K162682MATISSE Anterior Cervical Interbody Fusion Cage System K182151MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate K172788MONET™ Anterior Cervical Interbody Fusion Cage System K173185SEURAT™ Universal Pedicle Screw System K172212MATISSE Anterior Cervical Interbody Fusion Cage System, Ti-PEEK™ K192863MONDRIAN Lumbar Interbody Fusion Cage System

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Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre™, Shark™, Hornet™, Harpoon™), Choice Spine Interbody Fusion System (Harrier™), Choice Spine Vertebral Body Replacement System (Hawkeye™)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

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.

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