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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 K251522
Device Name Mg OSTEOINJECT™; Mg OSTEOREVIVE™; Mg OSTEOCRETE™
Applicant
Bone Solutions, Inc.
5712 Colleyville Blvd.
Suite 210
Colleyville,  TX  76034
Applicant Contact Drew Diaz
Correspondent
PaxMed International, LLC
1925 Palomar Oaks Way
Suite 210
Carlsbad,  CA  92008
Correspondent Contact Kevin Thomas
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Codes
MBP   OIS  
Date Received05/16/2025
Decision Date 10/13/2025
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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