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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 Integrated Fixation, Lumbar
510(k) Number K230731
Device Name Zavation ALIF System
Applicant
Zavation Medical Products, LLC
3670 Flowood Dr.
Flowood,  MS  39232
Applicant Contact Frankie Cummins
Correspondent
Zavation Medical Products, LLC
3670 Flowood Dr.
Flowood,  MS  39232
Correspondent Contact Frankie Cummins
Regulation Number888.3080
Classification Product Code
OVD  
Date Received03/16/2023
Decision Date 06/14/2023
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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