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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 K243526
Device Name MONTAGE Settable, Resorbable Bone Putty MONTAGE-QS Settable, Resorbable Bone Putty MONTAGE Flowable Settable, Resorbable Bone Paste MONTAGE-XT Settable, Resorbable Hemostatic Bone Putty
Applicant
Orthocon, Inc.
700 Fairfield Ave., Suite 1
Stamford,  CT  10533
Applicant Contact Aniq Darr
Correspondent
Mcra, LLC
803 7th St. NW, Floor 3
Washington,  DC  20001
Correspondent Contact Mehdi Kazemzadeh-Narbat
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
OIS  
Date Received11/14/2024
Decision Date 12/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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