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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 K133418
Device Name INTEGRA EXPANDABLE INTERVEREBRAL BODY FUSION DEVICE (IBD) SYSTEM
Applicant
Seaspine, Inc.
2302 La Mirada Dr.
Vista,  CA  92081 -7862
Applicant Contact JEFF BRITTAN
Correspondent
Seaspine, Inc.
2302 La Mirada Dr.
Vista,  CA  92081 -7862
Correspondent Contact JEFF BRITTAN
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/07/2013
Decision Date 05/01/2014
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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