Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
FDA 510(k) K223719 · Aegis Spine, Inc.
510(k) numberK223719
Submission
- Device name
- Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System
- Applicant
- Aegis Spine, Inc.
Englewood, CO, US - Received
- December 12, 2022
- Decision date
- January 11, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K223521 | ZESPIN SI Joint Fusion SystemOUR · Traditional | 01/20/2023SE |
| K221719 | ABTross ALIF Expandable Cage SystemMAX · Traditional | 11/03/2022SE |
| K221050 | ZESPIN SI Joint Fusion System, Paeon Posterior Cervical Fixation System, Paeon Anterior…OUR · Special | 06/30/2022SE |
| K210035 | ZESPIN SI Joint Fusion System, MegaCerfix Posterior Cervical Fixation System, MegaCerfix…OUR · Traditional | 02/16/2021SE |
| K203531 | XYPAN Expandable Lumbar Cage SystemMAX · Traditional | 01/29/2021SE |
Questions and answers
When was Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System cleared by the FDA?
Paeon Anterior Cervical Plate System, Elatus Lumbar Plate System (K223719) received a 510(k) decision of Substantially Equivalent on January 11, 2023, 30 days after the submission was received.
What is the product code of K223719?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.