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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 K253447
Device Name Montage Flowable Settable, Resorbable Bone Paste (Burr Hole Cover)
Applicant
Orthocon, Inc.
700 Fairfield Ave. - Suite 1
Stamford,  CT  06902
Applicant Contact Howard Schrayer
Correspondent
Orthocon, Inc.
700 Fairfield Ave. - Suite 1
Stamford,  CT  06902
Correspondent Contact Howard Schrayer
Regulation Number882.5250
Classification Product Code
GXR  
Subsequent Product Code
GXP  
Date Received10/02/2025
Decision Date 03/16/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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