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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 K091988
Device Name MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE , MODEL 9076
Applicant
VERTEBRAL TECHNOLOGIES, INC.
5909 Baker Road
Suite 550
Minnetonka,  MN  55345
Applicant Contact SURESH GHAI
Correspondent
VERTEBRAL TECHNOLOGIES, INC.
5909 Baker Road
Suite 550
Minnetonka,  MN  55345
Correspondent Contact SURESH GHAI
Regulation Number888.3080
Classification Product Code
MAX  
Date Received07/02/2009
Decision Date 07/30/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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