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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 K201781
Device Name Uni-FuZe-P Bone Putty
Applicant
Zavation Medical Products, LLC
220 Lakeland Pkwy.
Flowood,  MS  39232
Applicant Contact Steve Gordon
Correspondent
BioVera, Inc.
65 Promenade Saint Louis
Notre-Dame-De-Llle-Perrot,  CA J7V7P2
Correspondent Contact Robert A. Poggie
Regulation Number888.3045
Classification Product Code
MQV  
Date Received06/30/2020
Decision Date 12/28/2020
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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