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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 K221726
Device Name Uni-FuZe-C Bone Strip
Zavation Medical Products, LLC
3670 Flowood Drive
Flowood,  MS  39232
Applicant Contact Elke Carter
BioVera, Inc.
65 Promenade Saint Louis
Notre-Dame-de-L'lle-Perrot,  CA J7W3J6
Correspondent Contact Robert A Poggie
Regulation Number888.3045
Classification Product Code
Date Received06/14/2022
Decision Date 01/18/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No