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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 Integrated Fixation, Cervical
510(k) Number K221049
Device Name Zavation VariSync Plate System and VariSync Spacer System
Applicant
Zavation Medical Products, LLC
220 Lakeland Parkway
Flowood,  MS  39232
Applicant Contact Katie Motley
Correspondent
Zavation Medical Products, LLC
3670 Flowood Drive
Flowood,  MS  39232
Correspondent Contact Katie Motley
Regulation Number888.3080
Classification Product Code
OVE  
Subsequent Product Codes
KWQ   ODP  
Date Received04/11/2022
Decision Date 08/12/2022
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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