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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, Solid-Sphere, Lumbar
510(k) Number K060415
Device Name MODIFICATION TO: SATELLITE SPINAL SYSTEM
Applicant
Medtronic Sofamor Danek
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact RICHARD TREHARNE
Correspondent
Medtronic Sofamor Danek
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact RICHARD TREHARNE
Classification Product Code
NVR  
Date Received02/17/2006
Decision Date 01/05/2007
Decision SE - With Limitations (SESU)
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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