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FDA 510(k)

MONDRIAN Lumbar Interbody Fusion Cage System

K-Number: K192863 · 2020-08-26

ApplicantCtl Medical Corporation
Decision Date2020-08-26
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONDRIAN Lumbar Interbody Fusion Cage System is a medical device manufactured by Ctl Medical Corporation. It received FDA 510(k) clearance on 2020-08-26 under approval number K192863. 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 Lumbar Interbody Fusion Cage System?

MONDRIAN Lumbar Interbody Fusion Cage System is a medical device that received FDA 510(k) clearance on 2020-08-26. It is manufactured by Ctl Medical Corporation. The 510(k) number is K192863.

When was MONDRIAN Lumbar Interbody Fusion Cage System approved by the FDA?

MONDRIAN Lumbar Interbody Fusion Cage System received FDA 510(k) clearance on 2020-08-26, under approval number K192863.

What company makes MONDRIAN Lumbar Interbody Fusion Cage System?

MONDRIAN Lumbar Interbody Fusion Cage System is manufactured by Ctl Medical Corporation.

What is the FDA product code for MONDRIAN Lumbar Interbody Fusion Cage System?

The FDA product code for MONDRIAN Lumbar Interbody Fusion Cage System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05508360 "Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2) RECRUITING NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT04823858 3Spine Lumbar Fusion Real World Evidence Study ACTIVE_NOT_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION

Related PubMed Literature

PMID: 41839575 A Perspective for Integrating Real-World Evidence Into the Investigational Device Exemption Study Design for Lumbar Total Joint Replacement. International journal of spine surgery (2026) PMID: 41166829 Assessment of intra-operative impact durability of additively manufactured mock lumbar intervertebral body fusion devices. Journal of biomechanics (2026)

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™ K220334MONET Anterior Cervical Plate System

View all 14 devices →

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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