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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plate, Cranioplasty, Preformed, Non-Alterable
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
101 W. Dickman St., Suite 600
Baltimore,  MD  21230
Applicant Contact Brooke Lindsey
Correspondent
Longeviti Neuro Solutions
101 W. Dickman St., Suite 600
Baltimore,  MD  21230
Correspondent Contact Brooke Lindsey
Regulation Number882.5330
Classification Product Code
GXN  
Date Received03/04/2026
Decision Date 06/25/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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