Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Ctl Medical Corporation. It received FDA 510(k) clearance on 2022-11-09 under 510(k) 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. The listed applicant is Ctl Medical Corporation. The 510(k) number is K220334.

When did MONET Anterior Cervical Plate System receive FDA 510(k) clearance?

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

Who is the listed applicant for MONET Anterior Cervical Plate System?

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 Plate System?

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

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

Other records listing Ctl Medical Corporation as applicant

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.

K233947KLIMT™ Expandable Lumbar Interbody Fusion (LIF) Cage SystemK231715MONDRIAN™ Anterior Lumbar Plate SystemK231359RODIN™ Expandable Lumbar Cage SystemK220513NITRO Interbody Fusion Cage System FamilyK211785CASSATT™ SIJ Fixation SystemK213641MONDRIAN ALIF Cage with Supplementary Fixation Plate

View all 14 devices →

Related Devices (Code: KWQ)

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.

K261309Palisades™ Buttress Plate SystemBethesda Medical Devices, LLCK252776ARIES Anterior Cervical Plate SystemsZheJiang Decans Medical Devices Co., Ltd.K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.K260570corra™ cervical plating systemCarlsmed, Inc.K260697VyPlate™ Anterior Cervical Plate SystemVy Spine, LLCK260015ANTERIS Thoracolumbar Plate SystemSpineCraft

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.

↑