FDA 510(k) Application Details - K030601

Device Classification Name Spinal Vertebral Body Replacement Device

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510(K) Number K030601
Device Name Spinal Vertebral Body Replacement Device
Applicant MEDTRONIC SOFAMOR DANEK
1800 PYRAMID PLACE
MEMPHIS, TN 38132 US
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Contact RICHARD W TREHARNE
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Regulation Number 888.3060

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Classification Product Code MQP
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Date Received 02/25/2003
Decision Date 03/25/2003
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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