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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 bone graft, lumbar
510(k) Number K212811
Device Name Ti3Z Lumbar Interbody System
Applicant
Zavation Medical Products, LLC
220 Lakeland Parkway
Flowood,  MS  39232
Applicant Contact Katie Motley
Correspondent
Zavation Medical Products, LLC
220 Lakeland Parkway
Flowood,  MS  39232
Correspondent Contact Katie Motley
Regulation Number888.3080
Classification Product Code
MAX  
Date Received09/03/2021
Decision Date 04/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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