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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 K051320
Device Name SATELLITE SPINAL SYSTEM
Original Applicant
MEDTRONIC SOFAMOR DANEK
1800 pyramid place
memphis,  TN  38132
Original Contact richard w treharne
Classification Product Code
NVR  
Date Received05/20/2005
Decision Date 09/09/2005
Decision substantially equivalent - with limitations (SU)
Review Advisory Committee Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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