GXN — Plate, Cranioplasty, Preformed, Non-Alterable Class II
FDA Device Classification
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 |
|---|
| 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 |
| K170410 | longeviti neuro solutions | Longeviti PMMA Static Cranial Implant | March 23, 2018 |
| K171507 | fin-ceramica faenza | CustomizedBone Service | September 1, 2017 |
| K161090 | ossdsign | Cranial PSI | January 19, 2017 |