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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar
510(k) Number K202305
Device Name Zavation IBF System
Applicant
Zavation Medical Products, LLC
220 Lakeland Pkwy.
Flowood,  MS  39232
Applicant Contact Colby Williams
Correspondent
Zavation Medical Products, LLC
220 Lakeland Pkwy.
Flowood,  MS  39232
Correspondent Contact Colby Williams
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
ODP  
Date Received08/14/2020
Decision Date 10/13/2020
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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