Prase-AP Anterior Cervical Plate System
FDA 510(k) K202878 · Gbs Commonwealth Co., Ltd.
510(k) numberK202878
Submission
- Device name
- Prase-AP Anterior Cervical Plate System
- Applicant
- Gbs Commonwealth Co., Ltd.
Geumcheon-Gu, KR - Received
- September 28, 2020
- Decision date
- January 29, 2021
- 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 |
|---|---|---|
| K233839 | Peridot-PT Anterior Cervical Intervertebral body fusion System; Peridot-PT…ODP · Special | 12/20/2023SE |
| K233084 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…ODP · Traditional | 11/21/2023SE |
| K232292 | Peridot-EX Expandable Intervertebral Body Fusion SystemMAX · Traditional | 11/07/2023SE |
| K232822 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system), Anterior…ODP · Special | 10/13/2023SE |
| K230708 | Peridot-TD Spacer system (The Peridot-TD Intervertebral body fusion system); Anterior…ODP · Traditional | 05/22/2023SE |
| K213755 | Peridot-PT Anterior Cervical Intervertebral body fusion System, Peridot-PT…ODP · Traditional | 02/17/2023SE |
| K213980 | Peridot Spinal Interbody SystemODP · Traditional | 03/15/2022SE |
| K211205 | Prase-C Anterior Cervical Plate SystemKWQ · Traditional | 08/12/2021SE |
| K202872 | Prase PEEK Anterior Cervical Interbody SpacerODP · Traditional | 02/04/2021SE |
| K192026 | Peridot Intervertebral body fusion SystemMAX · Traditional | 11/26/2019SE |
Questions and answers
When was Prase-AP Anterior Cervical Plate System cleared by the FDA?
Prase-AP Anterior Cervical Plate System (K202878) received a 510(k) decision of Substantially Equivalent on January 29, 2021, 123 days after the submission was received.
What is the product code of K202878?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.