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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Intervertebral Body
510(k) Number K181244
Device Name Zavation Cervical Plate System
Applicant
Zavation Medical Products, LLC
220 Lakeland Pkwy.
Flowood,  MS  39232
Applicant Contact Matt Jones
Correspondent
Zavation Medical Products, LLC
220 Lakeland Pkwy.
Flowood,  MS  39232
Correspondent Contact Matt Jones
Regulation Number888.3060
Classification Product Code
KWQ  
Date Received05/10/2018
Decision Date 07/10/2018
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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