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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name spinal vertebral body replacement device - cervical
510(k) Number K191423
Device Name Normandy VBR System
Applicant
Zavation Medical Products LLC
220 Lakeland Parkway
Flowood,  MS  39232
Applicant Contact Frankie Cummins
Correspondent
Zavation Medical Products LLC
220 Lakeland Parkway
Flowood,  MS  39232
Correspondent Contact Frankie Cummins
Regulation Number888.3060
Classification Product Code
PLR  
Subsequent Product Code
MQP  
Date Received05/29/2019
Decision Date 08/06/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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