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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 K073291
Device Name CAPSTONE SPINAL SYSTEM
Applicant
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact LEE GRANT
Correspondent
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact LEE GRANT
Regulation Number888.3080
Classification Product Code
MAX  
Date Received11/23/2007
Decision Date 04/24/2008
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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