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FDA 510(k)

MONET™ Anterior Cervical Interbody Fusion Cage System

K-Number: K172788 · 2018-06-25

ApplicantCtl Medical Corporation
Decision Date2018-06-25
Product CodeODP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONET™ Anterior Cervical Interbody Fusion Cage System is a medical device manufactured by Ctl Medical Corporation. It received FDA 510(k) clearance on 2018-06-25 under approval number K172788. The device is classified under product code ODP. 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?

MONET™ Anterior Cervical Interbody Fusion Cage System is a medical device that received FDA 510(k) clearance on 2018-06-25. It is manufactured by Ctl Medical Corporation. The 510(k) number is K172788.

When was MONET™ Anterior Cervical Interbody Fusion Cage System approved by the FDA?

MONET™ Anterior Cervical Interbody Fusion Cage System received FDA 510(k) clearance on 2018-06-25, under approval number K172788.

What company makes MONET™ Anterior Cervical Interbody Fusion Cage System?

MONET™ Anterior Cervical Interbody Fusion Cage System is manufactured by Ctl Medical Corporation.

What is the FDA product code for MONET™ Anterior Cervical Interbody Fusion Cage System?

The FDA product code for MONET™ Anterior Cervical Interbody Fusion Cage System is ODP.

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 NCT06462729 LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF) RECRUITING NCT07606196 The Effect of Otolith Dysfunction and Its Rehabilitation in Vestibular Diseases COMPLETED NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT01630707 Evaluation of the Delivery of Optimized Supersaturated Oxygen Therapy to Treat Patients With an Acute Heart Attack COMPLETED

Related PubMed Literature

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 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: ODP)

K161127The Small PLATEAU (PLATEAU-C) Spacer SystemLife Spine, Inc. K162003IMSE Cervical CageThe Institute of Musculoskeletal Science & Education K160222OIC Cervical PEEK SpacerThe Orthopaedic Implant Company K161809ShurFit CpTi-HA ACIF Interbody Fusion SystemPrecision Spine, Inc. K162220DIO Medical IVA (ACIF, DLIF, PLIF, TLIF,and ALIF) CageDio Medical Co., Ltd. K161649Virtu C Spinal Implant SystemMet 1 Technologies, LLC

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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