Met One Czar Anterior Cervical Plate System
FDA 510(k) K180772 · Met One Technologies
510(k) numberK180772
Submission
- Device name
- Met One Czar Anterior Cervical Plate System
- Applicant
- Met One Technologies
El Paso, TX, US - Received
- March 23, 2018
- Decision date
- December 17, 2018
- 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 |
|---|---|---|
| K251732 | Wrist Fracture SystemHRS · Traditional | 02/12/2026SE |
| K250866 | Sovereign Posterior Cervical SystemNKG · Traditional | 05/20/2025SE |
| K230851 | Kodiak Lumbar Spacer SystemMAX · Traditional | 05/26/2023SE |
| K222806 | Kodiak C Spinal Implant SystemODP · Traditional | 12/22/2022SE |
| K193457 | AUDERE Lumbar Spacer SystemMAX · Traditional | 05/12/2020SE |
| K170108 | Xultan 5.5 Pedicle Screw SystemNKB · Traditional | 05/02/2017SE |
Questions and answers
When was Met One Czar Anterior Cervical Plate System cleared by the FDA?
Met One Czar Anterior Cervical Plate System (K180772) received a 510(k) decision of Substantially Equivalent on December 17, 2018, 269 days after the submission was received.
What is the product code of K180772?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.