DeviceClearance

ClearFit Ti Ring 14mm (171750) +4 more— 510(k) K260709

Substantially Equivalent

Longeviti Neuro Solutions

FDA 510(k) clearance K260709 for ClearFit Ti Ring 14mm (171750) +4 more, Substantially Equivalent on 2026-06-25. Applicant: Longeviti Neuro Solutions. Device class: 2.

Summary

Longeviti Neuro Solutions' clearance covers five ClearFit Ti Ring models: 14mm (171750), 14mm with Slot (171751), 20mm (171752), 20mm with Slot (171753), and 30mm (171754). They're filed under GXN, preformed non-alterable cranioplasty plates.

Class II, 21 CFR 882.5330. Neurology is both the classification panel and the review panel, and it came in as a Traditional 510(k).

Longeviti filed from Baltimore, Maryland. The decision came 113 calendar days after FDA received it (March 4 to June 25, 2026).

Clearance details

Device name as filed
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
Product code
Product code GXN
Device class
Class 2
Regulation
21 CFR 882.5330
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Baltimore, MD, US
Download summary PDFView on FDA.gov ↗

Recent devices under product code GXN

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Adverse events under product code GXN

product code GXN
Injury
208
Total
208

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.