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 |
|---|---|---|---|
| K250297 | techfit digital surgery | TECHFIT Patient-Specific Cranial System | October 27, 2025 |
| K250334 | kelyniam global | Fusion Craniofacial Implant; Fusion Skull Implant | July 25, 2025 |
| K231834 | 3d systems | VSP PEEK Cranial Implant | April 4, 2024 |
| K212391 | mci medical concept innovation | MCI-Neuro Fixation System | October 21, 2022 |
| K210360 | osteonic co | Neuro Plating System, Neuro Plating System Plates(NST304M02A and 61 Models), Neu | January 27, 2022 |
| K203055 | stryker | Stryker PEEK Customized Cranial Implant Kit | February 9, 2021 |
| K190811 | osteonic co | Optimus NEURO System - Sterile Kit | November 27, 2019 |
| K190229 | stryker | Stryker PEEK Customized Cranial Implant Kit | July 11, 2019 |
| K182711 | kelyniam global | Customized Craniofacial Implant (CCI), Customized Skull Implant (CSI) | May 21, 2019 |
| K183352 | osteonic co | Optimus Neuro System | January 2, 2019 |
| K182425 | stryker leibinger gmbh and co kg | Universal Mesh - Sterile | November 6, 2018 |
| K170725 | stryker | Stryker Universal Mesh | November 13, 2017 |
| K170368 | jeil medical corporation | Sterile NS System | September 11, 2017 |
| K161821 | stryker | Stryker Universal Mesh | December 8, 2016 |
| K161446 | ceremed | Biopor Porous Polyethylene Implants | September 27, 2016 |
| K153248 | stryker | PEEK Customized Cranial Implant | March 10, 2016 |
| K152076 | stryker | PEEK Customized Cranial Implant, PEEK Customized Cranial Implant Priority | August 26, 2015 |
| K141123 | alliance partners | ALLIANCE SPINE RAAS CRANIAL PLATING SYSTEM | February 27, 2015 |
| K141911 | osteonic co | OPTIMUS NEURO SYSTEM | February 10, 2015 |
| K141644 | innovasis | INNOVASIS CRANIAL SYSTEM | November 7, 2014 |