FDA 510(k) Application Details - K110522

Device Classification Name Appliance, Fixation, Spinal Interlaminal

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510(K) Number K110522
Device Name Appliance, Fixation, Spinal Interlaminal
Applicant MEDTRONIC SOFAMOR DANEK USA, INC.
1800 PYRAMID PLACE
MEMPHIS, TN 38132 US
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Contact NICHOLAS TABRIZI
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Regulation Number 888.3050

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Classification Product Code KWP
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Date Received 02/23/2011
Decision Date 04/01/2011
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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