FDA 510(k) Application Details - K062151

Device Classification Name Spinal Vertebral Body Replacement Device

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510(K) Number K062151
Device Name Spinal Vertebral Body Replacement Device
Applicant INNOVASIS, INC.
614 EAST 3900 SOUTH
SALT LAKE CITY, UT 84107 US
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Contact WARREN M DANSIE
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Regulation Number 888.3060

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Classification Product Code MQP
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Date Received 07/27/2006
Decision Date 12/22/2006
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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