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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, Cervical
510(k) Number K112664
Device Name ZAVATION IBF SYSTEMS
Applicant
Zavation, LLC
501 Avalon Way
Brandon,  MS  39047
Applicant Contact JOHN WALKER
Correspondent
Zavation, LLC
501 Avalon Way
Brandon,  MS  39047
Correspondent Contact JOHN WALKER
Regulation Number888.3080
Classification Product Code
ODP  
Subsequent Product Code
MAX  
Date Received09/13/2011
Decision Date 12/23/2011
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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