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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 K253732
Device Name Permatage Flowable, Settable Bone Paste
Applicant
Orthocon, Inc.
700 Fairfield Ave.
Suite 1
Stamford,  CT  06902
Applicant Contact Howard L. Schrayer
Correspondent
Orthocon, Inc.
700 Fairfield Ave.
Suite 1
Stamford,  CT  06902
Correspondent Contact Howard L. Schrayer
Regulation Number882.5300
Classification Product Code
GXP  
Date Received11/24/2025
Decision Date 03/13/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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