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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 K232771
Device Name Montage Flowable Settable, Resorbable Bone Paste
Applicant
Orthocon, Inc.
700 Fairfield Ave. - Suite 1
Stamford,  CT  06902
Applicant Contact Aniq Darr
Correspondent
Orthocon, Inc.
8 Lookout
Hilton Head Island,  SC  29928
Correspondent Contact Howard Schrayer
Regulation Number882.5300
Classification Product Code
GXP  
Date Received09/11/2023
Decision Date 02/16/2024
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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