EMERGE Anterior Cervical Plate System
FDA 510(k) K212405 · Evolution Spine
510(k) numberK212405
Submission
- Device name
- EMERGE Anterior Cervical Plate System
- Applicant
- Evolution Spine
Dallas, TX, US - Received
- August 2, 2021
- Decision date
- September 30, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 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 |
|---|---|---|
| K262094 | E3D-C Interbody SystemOVE · Special | 07/22/2026SE |
| K260038 | E3D-C Interbody SystemOVE · Special | 02/04/2026SE |
| K250167 | Evolution Spine Navigation InstrumentsOLO · Traditional | 08/18/2025SE |
| K241846 | E3D-C Interbody SystemOVE · Traditional | 08/12/2024SE |
| K240368 | E3D-A Interbody SystemOVD · Traditional | 05/15/2024SE |
| K232432 | E3D-A Interbody SystemOVD · Traditional | 01/30/2024SE |
| K223146 | EVOLUTION SPINE Interbody SystemOVD · Traditional | 02/07/2023SE |
| K220275 | EMERGE Anterior Cervical Plate SystemKWQ · Traditional | 03/18/2022SE |
| K182478 | Whistler Modular Pedicle Screw SystemNKB · Traditional | 01/15/2019SE |
| K180755 | Vail ALIF Buttress Plate SystemKWQ · Traditional | 07/06/2018SE |
Questions and answers
When was EMERGE Anterior Cervical Plate System cleared by the FDA?
EMERGE Anterior Cervical Plate System (K212405) received a 510(k) decision of Substantially Equivalent on September 30, 2021, 59 days after the submission was received.
What is the product code of K212405?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.