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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 K212991
Device Name Osteorevive
Applicant
Bone Solutions, Inc.
5712 Colleyville Blvd.
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 A Thomas
Regulation Number888.3045
Classification Product Code
MQV  
Subsequent Product Code
OIS  
Date Received09/20/2021
Decision Date 01/21/2022
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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