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510(k) K260709

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) by Longeviti Neuro Solutions — Product Code GXN

K260709 is an FDA 510(k) premarket notification submitted by Longeviti Neuro Solutions for the device "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)". The FDA issued a decision of Substantially Equivalent on June 25, 2026. The device falls under product code GXN (Plate, Cranioplasty, Preformed, Non-Alterable), a Class II device regulated under 21 CFR 882.5330. Longeviti Neuro Solutions has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2026
Date Received
March 4, 2026
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plate, Cranioplasty, Preformed, Non-Alterable
Device Class
Class II
Regulation Number
882.5330
Review Panel
NE
Submission Type

Other clearances by Longeviti Neuro Solutions

  • K231920 — Longeviti ClearFit OTS Cranial Implant (November 9, 2023)
  • K212058 — Longeviti ClearFit™ OTS Cranial Implants (September 8, 2021)
  • K211514 — Longeviti PorousFit implant (July 15, 2021)
  • K210616 — Longeviti PMMA Static Cranial Implant (March 31, 2021)
  • K203349 — Longeviti ClearFit Cranial Implant (December 16, 2020)
  • K202901 — Longeviti ClearFit Cranial Implant (October 30, 2020)
  • K191210 — Longeviti ClearFit Cranial Implant (January 9, 2020)
  • K170410 — Longeviti PMMA Static Cranial Implant (March 23, 2018)

Other clearances for product code GXN

  • K253116 — 3D MAC Titanium Cranial Plate (TCP) System (June 18, 2026)
  • K252251 — EASYMADE-TI (April 9, 2026)
  • K252958 — METICULY Patient-specific titanium mesh implant (January 14, 2026)
  • K243715 — Synthes Patient Specific Implants (November 12, 2025)
  • K252573 — KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosyn (November 10, 2025)
  • K240567 — CustomizedBone Service (March 28, 2024)
  • K231920 — Longeviti ClearFit OTS Cranial Implant (November 9, 2023)
  • K214109 — PEEK Patient Specific Cranial/Craniofacial Implant(PSCI) (October 28, 2022)
  • K220357 — MedCAD AccuShape Titanium Patient-Specific Cranial Implant (August 26, 2022)
  • K210099 — Meticuly Patient-Specific Titanium Mesh Implant (December 21, 2021)

FDA data resources