GWO — Plate, Cranioplasty, Preformed, Alterable Class II
FDA product code GWO covers "Plate, Cranioplasty, Preformed, Alterable", a Class II medical device regulated under 21 CFR 882.5320. Submissions are reviewed by the Neurology panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GWO
- Device Class
- Class II
- Regulation Number
- 882.5320
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K262874 | Cranius | CraniUS Plate | Sep 11, 2026 |
| K261058 | Cranius | CraniUS Plate | Jul 29, 2026 |
| K250297 | Techfit Digital Surgery | TECHFIT Patient-Specific Cranial System | Oct 27, 2025 |
| K250334 | Kelyniam Global | Fusion Craniofacial Implant; Fusion Skull Implant | Jul 25, 2025 |
| K231834 | 3D Systems | VSP PEEK Cranial Implant | Apr 4, 2024 |
| K212391 | Mci Medical Concept Innovation | MCI-Neuro Fixation System | Oct 21, 2022 |
| K210360 | Osteonic Co | Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neu | Jan 27, 2022 |
| K203055 | Stryker | Stryker PEEK Customized Cranial Implant Kit | Feb 9, 2021 |
| K190811 | Osteonic Co | Optimus NEURO System - Sterile Kit | Nov 27, 2019 |
| K190229 | Stryker | Stryker PEEK Customized Cranial Implant Kit | Jul 11, 2019 |
| K182711 | Kelyniam Global | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | May 21, 2019 |
| K183352 | Osteonic Co | Optimus Neuro System | Jan 2, 2019 |
| K182425 | Stryker Leibinger Gmbh And Co Kg | Universal Mesh - Sterile | Nov 6, 2018 |
| K170725 | Stryker | Stryker Universal Mesh | Nov 13, 2017 |
| K170368 | Jeil Medical Corporation | Sterile NS System | Sep 11, 2017 |
| K161821 | Stryker | Stryker Universal Mesh | Dec 8, 2016 |
| K161446 | Ceremed | Biopor Porous Polyethylene Implants | Sep 27, 2016 |
| K153248 | Stryker | PEEK Customized Cranial Implant | Mar 10, 2016 |
| K152076 | Stryker | PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority | Aug 26, 2015 |
| K141123 | Alliance Partners | ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM | Feb 27, 2015 |