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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 K221644
Device Name Synthetic Bone Putty
Applicant
Ventris Medical
1201 Dove St.
Suite 470
Newport Beach,  CA  92660
Applicant Contact John Brunelle
Correspondent
Ventris Medical
1201 Dove St.
Suite 470
Newport Beach,  CA  92660
Correspondent Contact John Brunelle
Regulation Number888.3045
Classification Product Code
MQV  
Date Received06/06/2022
Decision Date 09/02/2022
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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