FDA 510(k) Application Details - K070218

Device Classification Name Spinal Vertebral Body Replacement Device

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510(K) Number K070218
Device Name Spinal Vertebral Body Replacement Device
Applicant VERTIFLEX (TM), INCORPORATED
1954 KELLOGG AVENUE, SUITE 100
CARLSBAD, CA 92008 US
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Contact STEVE REITZLER
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Regulation Number 888.3060

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Classification Product Code MQP
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Date Received 01/23/2007
Decision Date 04/06/2007
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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