X-PAC® N-GAGE Lumbar Plate System
FDA 510(k) K250602 · Expanding Innovations, Inc.
510(k) numberK250602
Submission
- Device name
- X-PAC® N-GAGE Lumbar Plate System
- Applicant
- Expanding Innovations, Inc.
Mountain View, CA, US - Received
- February 28, 2025
- Decision date
- May 20, 2025
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K251003 | X-PAC® LLIF Expandable Lateral Cage SystemMAX · Traditional | 06/25/2025SE |
| K251617 | X-PAC® TLIF Expandable Posterior Cage System; X-PAC® LLIF Expandable Lateral Cage SystemMAX · Special | 06/16/2025SE |
| K223174 | X-Pac Expandable LLIF Cage SystemMAX · Traditional | 02/14/2023SE |
| K222797 | X-Pac Expandable Lumbar Cage SystemMAX · Special | 10/14/2022SE |
| K220655 | X-Pac Expandable Lumbar Cage SystemMAX · Special | 03/24/2022SE |
| K203802 | X-Pac Expandable Lumbar Cage SystemMAX · Traditional | 06/07/2021SE |
| K201145 | X-Pac Expandable Lumbar Cage SystemMAX · Traditional | 09/10/2020SE |
Questions and answers
When was X-PAC® N-GAGE Lumbar Plate System cleared by the FDA?
X-PAC® N-GAGE Lumbar Plate System (K250602) received a 510(k) decision of Substantially Equivalent on May 20, 2025, 81 days after the submission was received.
What is the product code of K250602?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.