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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 Avenue - 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
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