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FDA 510(k) Application Details - K060415
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
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510(K) Number
K060415
Device Name
Intervertebral Fusion Device With Bone Graft, Solid-Sphere, Lumbar
Applicant
MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS, TN 38132 US
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Contact
RICHARD TREHARNE
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Regulation Number
000.0000
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Classification Product Code
NVR
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More FDA Info for this Product Code
Date Received
02/17/2006
Decision Date
01/05/2007
Decision
SESU - SE - WITH LIMITATIONS
Classification Advisory Committee
-
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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