MVP Cervical Plate System
FDA 510(k) K190170 · GS Medical Co., Ltd.
510(k) numberK190170
Submission
- Device name
- MVP Cervical Plate System
- Applicant
- GS Medical Co., Ltd.
Osong-Eup, KR - Received
- February 1, 2019
- Decision date
- May 13, 2019
- 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 |
|---|---|---|
| K243073 | AnyPlus Navigated Instruments SystemOLO · Traditional | 12/06/2024SE |
| K241738 | PYXIS 3D Titanium Cervical Cage systemODP · Traditional | 08/20/2024SE |
| K240350 | AnyPlus II Spinal Fixation SystemNKB · Traditional | 04/03/2024SE |
| K231808 | QUASAR Standalone ACIF SystemOVE · Special | 07/20/2023SE |
| K223868 | PYXIS 3D Titanium Cage SystemMAX · Traditional | 04/26/2023SE |
| K222041 | CYGNUS-C Standalone ACIF SystemOVE · Traditional | 02/09/2023SE |
| K221687 | Pegasus-X Expandable PLIF SystemMAX · Traditional | 07/27/2022SE |
| K211797 | TRACKER Plus Kyphoplasty SystemNDN · Traditional | 10/28/2021SE |
| K200592 | GS Medical AnyPlus PEEK Cage SystemODP · Traditional | 08/10/2020SE |
| K192335 | TRACKER Kyphoplasty SystemNDN · Traditional | 12/04/2019SE |
Questions and answers
When was MVP Cervical Plate System cleared by the FDA?
MVP Cervical Plate System (K190170) received a 510(k) decision of Substantially Equivalent on May 13, 2019, 101 days after the submission was received.
What is the product code of K190170?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.