Longeviti ClearFit Cranial Implant
FDA 510(k) K202901 · Longeviti Neuro Solutions, LLC
510(k) numberK202901
Submission
- Device name
- Longeviti ClearFit Cranial Implant
- Applicant
- Longeviti Neuro Solutions, LLC
Hunt Valley, MD, US - Received
- September 29, 2020
- Decision date
- October 30, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code GXN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260709 | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring…GXN · Traditional | Longeviti Neuro Solutions | 06/25/2026SE |
| K253116 | 3D MAC Titanium Cranial Plate (TCP) SystemGXN · Traditional | The Surgeon General, Department of the Army… | 06/18/2026SE |
| K252251 | Easymade-TiGXN · Traditional | CG Bio Co., Ltd. | 04/09/2026SE |
| K252958 | METICULY Patient-specific titanium mesh implantGXN · Traditional | Meticuly Co., Ltd. | 01/14/2026SE |
| K243715 | Synthes Patient Specific ImplantsGXN · Traditional | Synthes GmbH | 11/12/2025SE |
| K252573 | KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis…GXN · Traditional | KLS-Martin L.P. | 11/10/2025SE |
| K240567 | CustomizedBone ServiceGXN · Special | Fin-Ceramica Faenza S.P.A. | 03/28/2024SE |
| K231920 | Longeviti ClearFit OTS Cranial ImplantGXN · Special | Longeviti Neuro Solutions, LLC | 11/09/2023SE |
| K214109 | PEEK Patient Specific Cranial/Craniofacial Implant(PSCI)GXN · Traditional | Kontour(XiAn) Medical Technology Co., Ltd. | 10/28/2022SE |
| K220357 | MedCAD AccuShape Titanium Patient-Specific Cranial ImplantGXN · Traditional | Medcad | 08/26/2022SE |
More from Medcad
| 510(k) | Device | Decision |
|---|---|---|
| K260709 | ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring…GXN · Traditional | 06/25/2026SE |
| K231920 | Longeviti ClearFit OTS Cranial ImplantGXN · Special | 11/09/2023SE |
| K212058 | Longeviti ClearFit OTS Cranial ImplantsGXN · Traditional | 09/08/2021SE |
| K211514 | Longeviti PorousFit implantKKY · Traditional | 07/15/2021SE |
| K210616 | Longeviti PMMA Static Cranial ImplantGXN · Special | 03/31/2021SE |
| K203349 | Longeviti ClearFit Cranial ImplantGXN · Special | 12/16/2020SE |
| K191210 | Longeviti ClearFit Cranial ImplantGXN · Traditional | 01/09/2020SE |
| K170410 | Longeviti PMMA Static Cranial ImplantGXN · Traditional | 03/23/2018SE |
Questions and answers
When was Longeviti ClearFit Cranial Implant cleared by the FDA?
Longeviti ClearFit Cranial Implant (K202901) received a 510(k) decision of Substantially Equivalent on October 30, 2020, 31 days after the submission was received.
What is the product code of K202901?
The FDA product code is GXN – Plate, Cranioplasty, Preformed, Non-Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5330.