K260709
- 510(k) number
- K260709
- 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 MD · US
- Product code
- GXN — Plate, Cranioplasty, Preformed, Non-Alterable
- Decision date
- 2026-06-25
- Date received
- 2026-03-04
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K260709.pdf
Official FDA record: K260709
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.