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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 K242372
Device Name Mg OSTEOREVIVE™, Mg OSTEOCRETE™
Applicant
Bone Solutions, Inc
5712 Colleyville Boulevard
Suite 210
Colleyville,  TX  76034
Applicant Contact Drew Diaz
Correspondent
PaxMed International, LLC
12264 El Camino Real
Suite 400
San Diego,  CA  92130
Correspondent Contact Kevin Thomas
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Codes
MBP   OIS  
Date Received08/09/2024
Decision Date 10/18/2024
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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