ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)
FDA 510(k) K260709 · Longeviti Neuro Solutions
510(k) numberK260709
Submission
- Device name
- ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754)
- Applicant
- Longeviti Neuro Solutions
Baltimore, MD, US - Received
- March 4, 2026
- Decision date
- June 25, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code GXN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
| K210099 | Meticuly Patient-Specific Titanium Mesh ImplantGXN · Traditional | Meticuly Co., Ltd. | 12/21/2021SE |
More from Meticuly Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K202901 | Longeviti ClearFit Cranial ImplantGXN · Special | 10/30/2020SE |
| K191210 | Longeviti ClearFit Cranial ImplantGXN · Traditional | 01/09/2020SE |
| K170410 | Longeviti PMMA Static Cranial ImplantGXN · Traditional | 03/23/2018SE |
Questions and answers
When was ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754) cleared by the FDA?
ClearFit Ti Ring 14mm (171750);ClearFit Ti Ring 14mm with Slot (171751);ClearFit Ti Ring 20mm (171752);ClearFit Ti Ring 20mm with Slot (171753);ClearFit Ti Ring 30mm (171754) (K260709) received a 510(k) decision of Substantially Equivalent on June 25, 2026, 113 days after the submission was received.
What is the product code of K260709?
The FDA product code is GXN – Plate, Cranioplasty, Preformed, Non-Alterable, a Class II (moderate risk) device regulated under 21 CFR 882.5330.