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FDA 510(k)

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate

K-Number: K182151 · 2018-10-11

ApplicantCtl Medical Corporation
Decision Date2018-10-11
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate is a medical device manufactured by Ctl Medical Corporation. It received FDA 510(k) clearance on 2018-10-11 under approval number K182151. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate?

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate is a medical device that received FDA 510(k) clearance on 2018-10-11. It is manufactured by Ctl Medical Corporation. The 510(k) number is K182151.

When was MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate approved by the FDA?

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate received FDA 510(k) clearance on 2018-10-11, under approval number K182151.

What company makes MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate?

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate is manufactured by Ctl Medical Corporation.

What is the FDA product code for MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate?

The FDA product code for MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate is OVE.

Related Clinical Trials

NCT07301385 Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety and Workflow Study ACTIVE_NOT_RECRUITING 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 NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07608380 Accuracy of Positioning Guide and Customized Plate in Zygomaticomaxillary Complex Fractures ENROLLING_BY_INVITATION NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED

Related PubMed Literature

PMID: 38273730 Ten-Year Risk of Recall of Novel Spine Devices. Spine (2024) PMID: 28256243 Mechanical performance of cervical intervertebral body fusion devices: A systematic analysis of data submitted to the Food and Drug Administration. Journal of biomechanics (2017)

Other Devices by Ctl Medical Corporation

K162682MATISSE Anterior Cervical Interbody Fusion Cage System 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 K220334MONET Anterior Cervical Plate System

View all 14 devices →

Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, 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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