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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Methyl Methacrylate For Cranioplasty
510(k) Number K253854
Device Name MONTAGE XT Cranial Cement
Applicant
Orthocon, Inc.
700 Fairfield Ave.
Suite 1
Stamford,  CT  06902
Applicant Contact Alyssa McDermott
Correspondent
Orthocon, Inc.
700 Fairfield Ave.
Suite 1
Stamford,  CT  06902
Correspondent Contact Alyssa McDermott
Regulation Number882.5300
Classification Product Code
GXP  
Date Received12/03/2025
Decision Date 01/02/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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