FDA 510(k) Application Details - K060794

Device Classification Name Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)

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510(K) Number K060794
Device Name Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
Applicant MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS, TN 38132 US
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Contact EDWARD S CHIN
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Regulation Number 888.3045

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Classification Product Code MBP
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Date Received 03/23/2006
Decision Date 12/18/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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