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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 K101235
Device Name CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM
Applicant
Neos Surgery S.L
901 King St., Suite 200
Alexandria,  VA  22314
Applicant Contact MARCOS VELEZ-DURAN
Correspondent
Neos Surgery S.L
901 King St., Suite 200
Alexandria,  VA  22314
Correspondent Contact MARCOS VELEZ-DURAN
Regulation Number882.5250
Classification Product Code
GXR  
Date Received05/03/2010
Decision Date 10/25/2010
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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