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FDA 510(k)

MONET Anterior Cervical Plate System

K-Number: K220334 · 2022-11-09

ApplicantCtl Medical Corporation
Decision Date2022-11-09
Product CodeKWQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MONET Anterior Cervical Plate System is a medical device manufactured by Ctl Medical Corporation. It received FDA 510(k) clearance on 2022-11-09 under approval number K220334. The device is classified under product code KWQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONET Anterior Cervical Plate System?

MONET Anterior Cervical Plate System is a medical device that received FDA 510(k) clearance on 2022-11-09. It is manufactured by Ctl Medical Corporation. The 510(k) number is K220334.

When was MONET Anterior Cervical Plate System approved by the FDA?

MONET Anterior Cervical Plate System received FDA 510(k) clearance on 2022-11-09, under approval number K220334.

What company makes MONET Anterior Cervical Plate System?

MONET Anterior Cervical Plate System is manufactured by Ctl Medical Corporation.

What is the FDA product code for MONET Anterior Cervical Plate System?

The FDA product code for MONET Anterior Cervical Plate System is KWQ.

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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: KWQ)

K160982Sphynx™Eden Spine, LLC K162638CETRA Anterior Cervical Plate SystemOrthofix, Inc. K162194MEDICREA INTERNATIONAL Anterior Cervical Locking Plate SystemMedicrea International SA K162211AccuFit Lateral Plate SystemPrecision Spine, Inc. K162250FortiBridge Anterior Cervical Plate SystemNanovis Spine, LLC K162664Pyrenees Cervical Plate SystemK2m, 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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