FDA 510(k) Application Details - K090841

Device Classification Name Spinal Vertebral Body Replacement Device

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510(K) Number K090841
Device Name Spinal Vertebral Body Replacement Device
Applicant ULRICH GMBH & CO. KG
754 SPIRIT 40 PARK DRIVE
CHESTERFIELD, MO 63005 US
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Contact MERLE SYMES
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Regulation Number 888.3060

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Classification Product Code MQP
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Date Received 03/27/2009
Decision Date 10/05/2009
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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