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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 K080673
Device Name INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE
Applicant
Vertebral Technologies, Inc.
14289 Yellowpine
Andover,  MN  55304
Applicant Contact PHILIP B JARVI
Correspondent
Vertebral Technologies, Inc.
14289 Yellowpine
Andover,  MN  55304
Correspondent Contact PHILIP B JARVI
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/10/2008
Decision Date 06/10/2008
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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