FDA 510(k) Application Details - K021705

Device Classification Name System, Facet Screw Spinal Device

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510(K) Number K021705
Device Name System, Facet Screw Spinal Device
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 000.0000

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Classification Product Code MRW
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Date Received 05/23/2002
Decision Date 07/24/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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