GXN — Plate, Cranioplasty, Preformed, Non-Alterable Class II
FDA product code GXN covers "Plate, Cranioplasty, Preformed, Non-Alterable", a Class II medical device regulated under 21 CFR 882.5330. 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
- GXN
- Device Class
- Class II
- Regulation Number
- 882.5330
- Submission Type
- Review Panel
- NE
- Medical Specialty
- Neurology
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260709 | longeviti neuro solutions | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit | June 25, 2026 |
| K253116 | surgeon general, department of the army (tsg-da) | 3D MAC Titanium Cranial Plate (TCP) System | June 18, 2026 |
| K252251 | cg bio co | EASYMADE-TI | April 9, 2026 |
| K252958 | meticuly co | METICULY Patient-specific titanium mesh implant | January 14, 2026 |
| K243715 | synthes | Synthes Patient Specific Implants | November 12, 2025 |
| K252573 | kls-martin l.p | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosyn | November 10, 2025 |
| K240567 | fin-ceramica faenza | CustomizedBone Service | March 28, 2024 |
| K231920 | longeviti neuro solutions | Longeviti ClearFit OTS Cranial Implant | November 9, 2023 |
| K214109 | kontour(xian) medical technology co | PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) | October 28, 2022 |
| K220357 | medcad | MedCAD AccuShape Titanium Patient-Specific Cranial Implant | August 26, 2022 |
| K210099 | meticuly co | Meticuly Patient-Specific Titanium Mesh Implant | December 21, 2021 |
| K212058 | longeviti neuro solutions | Longeviti ClearFit OTS Cranial Implants | September 8, 2021 |
| K210616 | longeviti neuro solutions | Longeviti PMMA Static Cranial Implant | March 31, 2021 |
| K203349 | longeviti neuro solutions | Longeviti ClearFit Cranial Implant | December 16, 2020 |
| K202901 | longeviti neuro solutions | Longeviti ClearFit Cranial Implant | October 30, 2020 |
| K192702 | synthes (usa) products | DePuy Synthes Craniomaxillofacial Neuro Devices - MR Conditional | September 18, 2020 |
| K193547 | fin-ceramica faenza | CustomizedBone Service | January 17, 2020 |
| K191210 | longeviti neuro solutions | Longeviti ClearFit Cranial Implant | January 9, 2020 |
| K180064 | oxford performance materials | OsteoFab Patient Specific Cranial Device | July 27, 2018 |
| K180513 | fin-ceramica faenza | CustomizedBone Service | May 15, 2018 |