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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Posterior Cervical Screw System
510(k) Number K211993
Device Name Z-LINKPC 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 Number888.3075
Classification Product Code
NKG  
Subsequent Product Code
KWP  
Date Received06/28/2021
Decision Date 08/11/2021
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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