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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 K162087
Device Name NovoGro
Applicant
Osteonovus, Inc.
1510 N. Westwood Ave., Suite 1080
Toledo,  OH  43606
Applicant Contact Brian M. Schlossberg
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  
Date Received07/28/2016
Decision Date 04/18/2017
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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