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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 K233509
Device Name Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System
Applicant
Zavation Medical Products LLC
3670 Flowood Drive
Flowood,  MS  39232
Applicant Contact Colby Williams
Correspondent
Zavation Medical Products LLC
3670 Flowood Drive
Flowood,  MS  39232
Correspondent Contact Colby Williams
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Codes
KWP   OVD   OVE  
Date Received10/31/2023
Decision Date 04/10/2024
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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