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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cover, Burr Hole
510(k) Number K240137
Device Name Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System
Applicant
Neos Surgery S.L
Ceramistes 2
Cerdanyola,  ES 08290
Applicant Contact Eduard Garcia
Correspondent
Neos Surgery S.L
Ceramistes 2
Cerdanyola,  ES 08290
Correspondent Contact Eduard Garcia
Regulation Number882.5250
Classification Product Code
GXR  
Date Received01/18/2024
Decision Date 02/16/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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