CraniUS Plate
FDA 510(k) K261058 · CraniUS, LLC
510(k) numberK261058
Submission
- Device name
- CraniUS Plate
- Applicant
- CraniUS, LLC
Baltimore, MD, US - Received
- March 31, 2026
- Decision date
- July 29, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GWO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262874 | CraniUS PlateGWO · Special | CraniUS, LLC | 09/11/2026SE |
| K250297 | TECHFIT Patient-Specific Cranial SystemGWO · Traditional | Techfit Digital Surgery, Inc. | 10/27/2025SE |
| K250334 | Fusion Craniofacial Implant; Fusion Skull ImplantGWO · Traditional | Kelyniam Global, Inc. | 07/25/2025SE |
| K231834 | VSP PEEK Cranial ImplantGWO · Traditional | 3D Systems, Inc. | 04/04/2024SE |
| K212391 | MCI-Neuro Fixation SystemGWO · Traditional | Mci Medical Concept Innovation, Inc. | 10/21/2022SE |
| K210360 | Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neuro…GWO · Traditional | Osteonic Co., Ltd. | 01/27/2022SE |
| K203055 | Stryker PEEK Customized Cranial Implant KitGWO · Traditional | Stryker | 02/09/2021SE |
| K190811 | Optimus NEURO System - Sterile KitGWO · Traditional | Osteonic Co., Ltd. | 11/27/2019SE |
| K190229 | Stryker PEEK Customized Cranial Implant KitGWO · Traditional | Stryker | 07/11/2019SE |
| K182711 | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI)GWO · Traditional | Kelyniam Global, Inc. | 05/21/2019SE |
More from Kelyniam Global, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K262874 | CraniUS PlateGWO · Special | 09/11/2026SE |
Questions and answers
When was CraniUS Plate cleared by the FDA?
CraniUS Plate (K261058) received a 510(k) decision of Substantially Equivalent on July 29, 2026, 120 days after the submission was received.
What is the product code of K261058?
The FDA product code is GWO – Plate, Cranioplasty, Preformed, Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5320.