FDA 510(k) Application Details - K021106

Device Classification Name Orthosis, Spinal Pedicle Fixation

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510(K) Number K021106
Device Name Orthosis, Spinal Pedicle Fixation
Applicant MEDTRONIC SOFAMOR DANEK, INC.
1800 PYRAMID PLACE
MEMPHIS, TN 38132 US
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Contact RICHARD TREHARNE
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Regulation Number 888.3070

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Classification Product Code MNI
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Date Received 04/05/2002
Decision Date 05/03/2002
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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