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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Filler, Bone Void, Calcium Compound
510(k) Number K231903
Device Name Montage-QS Settable, Resorbable Bone Putty
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 Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
OIS  
Date Received06/28/2023
Decision Date 08/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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