FDA 510(k) Application Details - K062004

Device Classification Name Spinal Vertebral Body Replacement Device

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510(K) Number K062004
Device Name Spinal Vertebral Body Replacement Device
Applicant QUANTUM ORTHOPEDICS, INC.
2744 LOKER AVE. W. SUITE 100
CARLSBAD, CA 92008 US
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Contact KERRI DIMARTINO
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Regulation Number 888.3060

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Classification Product Code MQP
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Date Received 07/17/2006
Decision Date 08/15/2006
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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