VSP PEEK Cranial Implant
FDA 510(k) K231834 · 3D Systems, Inc.
510(k) numberK231834
Submission
- Device name
- VSP PEEK Cranial Implant
- Applicant
- 3D Systems, Inc.
Littleton, CO, US - Received
- June 22, 2023
- Decision date
- April 4, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K262874 | CraniUS PlateGWO · Special | CraniUS, LLC | 09/11/2026SE |
| K261058 | CraniUS PlateGWO · Traditional | CraniUS, LLC | 07/29/2026SE |
| 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 |
| 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 |
|---|---|---|
| K261826 | VSP System (Titanium Palatal Splint)DZJ · Traditional | 06/03/2026SE |
| K250711 | VSP Orthopedics SystemPBF · Traditional | 12/05/2025SE |
| K243174 | Cadence Ankle PSI SystemOYK · Special | 10/25/2024SE |
| K243173 | Salto Talaris Ankle PSI SystemOYK · Special | 10/25/2024SE |
| K241326 | Cadence Ankle PSI SystemOYK · Traditional | 08/30/2024SE |
| K241148 | Salto Talaris Ankle PSI SystemOYK · Traditional | 08/30/2024SE |
| K231585 | Vantage PSI SystemOYK · Special | 06/30/2023SE |
| K214093 | VSP BolusIXI · Traditional | 03/30/2022SE |
| K211244 | VSP® Orthopedics SystemPBF · Traditional | 11/10/2021SE |
| K210347 | VSP SystemDZJ · Traditional | 04/26/2021SE |
Questions and answers
When was VSP PEEK Cranial Implant cleared by the FDA?
VSP PEEK Cranial Implant (K231834) received a 510(k) decision of Substantially Equivalent on April 4, 2024, 287 days after the submission was received.
What is the product code of K231834?
The FDA product code is GWO – Plate, Cranioplasty, Preformed, Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5320.