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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 K090707
Device Name TALOS INTERVERTEBRAL BODY FUSION DEVICE
Applicant
Meditech Advisors, LLC
950 N. Michigan Ave.
Suite 2202
Chicago,  IL  60611
Applicant Contact JANET M WEBB
Correspondent
Meditech Advisors, LLC
950 N. Michigan Ave.
Suite 2202
Chicago,  IL  60611
Correspondent Contact JANET M WEBB
Regulation Number888.3080
Classification Product Code
MAX  
Date Received03/17/2009
Decision Date 07/15/2009
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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