FDA 510(k) Application Details - K061274

Device Classification Name Appliance, Fixation, Spinal Intervertebral Body

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510(K) Number K061274
Device Name Appliance, Fixation, Spinal Intervertebral Body
Applicant MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS, TN 38132 US
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Contact RICHARD TREHAME
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Regulation Number 888.3060

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Classification Product Code KWQ
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Date Received 05/08/2006
Decision Date 05/25/2006
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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