FDA 510(k) Application Details - K072326

Device Classification Name Spinal Vertebral Body Replacement Device

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510(K) Number K072326
Device Name Spinal Vertebral Body Replacement Device
Applicant CO-LIGNE AG
1070 CONRAD AVENUE, SUITE 230
CONCORD, CA 94520 US
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Contact DAVID SCHLERF
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Regulation Number 888.3060

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Classification Product Code MQP
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Date Received 08/20/2007
Decision Date 06/24/2008
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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