FDA 510(k)

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate

K-Number: K182151 · 2018-10-11

Decision Date2018-10-11

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate is the device name listed in this FDA 510(k) record. The listed applicant is Ctl Medical Corporation. It received FDA 510(k) clearance on 2018-10-11 under 510(k) 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. The listed applicant is Ctl Medical Corporation. The 510(k) number is K182151.

When did MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate receive FDA 510(k) clearance?

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

Who is the listed applicant for MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation Plate?

The FDA 510(k) record lists Ctl Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATION NCT04214535Anterior Cervical Disectomy And Fusion Using The Tritanium® C Anterior Cervical Cage For One Or Two-LevelsACTIVE_NOT_RECRUITING NCT05883436Investigation of DEXA-C Anterior Cervical Interbody SystemACTIVE_NOT_RECRUITING NCT07739979Radiological Outcome of Bony Fusion After Single Level Anterior Cervical Discectomy and Fusion Using Iliac Crest Graft vs. Polyetheretherketone Cage in Cervical SpondylosisCOMPLETED NCT04388332ACDF Using Structural Allograft vs. Tritanium CRECRUITING NCT05740176The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion SurgeryACTIVE_NOT_RECRUITING

Other records listing Ctl Medical Corporation as applicant

K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage System K231715MONDRIAN™ Anterior Lumbar Plate System K231359RODIN™ Expandable Lumbar Cage System K220513NITRO Interbody Fusion Cage System Family K220334MONET Anterior Cervical Plate System K211785CASSATT™ SIJ Fixation System

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Related Devices (Code: OVE)

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution Spine K261279DeltaNEC Interbody SystemNexus Spine K252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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.