MONET Anterior Cervical Plate System
FDA 510(k) K220334 · Ctl Medical Corporation
510(k) numberK220334
Submission
- Device name
- MONET Anterior Cervical Plate System
- Applicant
- Ctl Medical Corporation
Addison, TX, US - Received
- February 4, 2022
- Decision date
- November 9, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code KWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261309 | Palisades Buttress Plate SystemKWQ · Traditional | Bethesda Medical Devices, LLC | 07/16/2026SE |
| K252776 | ARIES Anterior Cervical Plate SystemsKWQ · Traditional | ZheJiang Decans Medical Devices Co., Ltd. | 05/14/2026SE |
| K261112 | CastleLoc-P Anterior Cervical Plate SystemKWQ · Special | L&K BIOMED Co., Ltd. | 05/06/2026SE |
| K260570 | corra cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 04/22/2026SE |
| K260697 | VyPlate Anterior Cervical Plate SystemKWQ · Special | Vy Spine, LLC | 03/27/2026SE |
| K260015 | ANTERIS Thoracolumbar Plate SystemKWQ · Traditional | SpineCraft | 03/04/2026SE |
| K251940 | PathLoc Lumbar Plate SystemKWQ · Traditional | L&K BIOMED Co., Ltd. | 03/03/2026SE |
| K254182 | AsterKWQ · Traditional | Osteonic Co., Ltd. | 02/26/2026SE |
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special | 4Web, Inc. | 02/12/2026SE |
| K252611 | aprevo® cervical plating systemKWQ · Traditional | Carlsmed, Inc. | 12/22/2025SE |
More from Carlsmed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K233947 | KLIMT Expandable Lumbar Interbody Fusion (LIF) Cage SystemMAX · Traditional | 10/10/2024SE |
| K231715 | MONDRIAN Anterior Lumbar Plate SystemKWQ · Traditional | 01/26/2024SE |
| K231359 | RODIN Expandable Lumbar Cage SystemMAX · Special | 06/09/2023SE |
| K220513 | NITRO Interbody Fusion Cage System FamilyODP · Traditional | 04/25/2023SE |
| K211785 | CASSATT SIJ Fixation SystemOUR · Traditional | 10/17/2022SE |
| K213641 | MONDRIAN ALIF Cage with Supplementary Fixation PlateMAX · Traditional | 09/15/2022SE |
| K213491 | Universal Pilot Guidance Instrument SystemOLO · Traditional | 05/12/2022SE |
| K192863 | MONDRIAN Lumbar Interbody Fusion Cage SystemMAX · Traditional | 08/26/2020SE |
| K182151 | MONET Anterior Cervical Interbody Fusion Cage System with Supplementary Fixation PlateOVE · Traditional | 10/11/2018SE |
| K172788 | MONET Anterior Cervical Interbody Fusion Cage SystemODP · Traditional | 06/25/2018SE |
Questions and answers
When was MONET Anterior Cervical Plate System cleared by the FDA?
MONET Anterior Cervical Plate System (K220334) received a 510(k) decision of Substantially Equivalent on November 9, 2022, 278 days after the submission was received.
What is the product code of K220334?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.