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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 K261265
Device Name Permatage XT Settable Bone Putty
Applicant
Orthocon, Inc.
700 Fairfield Ave., Suite 1
Stamford,  CT  06902
Applicant Contact Alyssa McDermott
Correspondent
Abyrx, Inc.
700 Fairfield Ave., Suite 1
Stamford,  CT  06902
Correspondent Contact Alyssa McDermott
Regulation Number882.5300
Classification Product Code
GXP  
Date Received04/16/2026
Decision Date 06/15/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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