FDA 510(k) Application Details - K050861

Device Classification Name Spinal Vertebral Body Replacement Device

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510(K) Number K050861
Device Name Spinal Vertebral Body Replacement Device
Applicant INTERPORE CROSS INTL.
181 TECHNOLOGY DR.
IRVINE, CA 92618-2402 US
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Contact WENDY SPIELBERGER
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Regulation Number 888.3060

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Classification Product Code MQP
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Date Received 04/05/2005
Decision Date 05/27/2005
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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