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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Spinous Process Plate
510(k) Number K161016
Device Name Z-Clamp ISP System
Applicant
Zavation, LLC
220 Lakeland Pkwy.
Flowood,  MS  39232
Applicant Contact James M Philips
Correspondent
Zavation, LLC
220 Lakeland Pkwy.
Flowood,  MS  39232
Correspondent Contact Milton Phillips
Regulation Number888.3050
Classification Product Code
PEK  
Date Received04/11/2016
Decision Date 10/19/2016
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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