FDA 510(k) Application Details - K051454

Device Classification Name Spinal Vertebral Body Replacement Device

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510(K) Number K051454
Device Name Spinal Vertebral Body Replacement Device
Applicant K2M, LLC
751 MILLER DR.,S.E., SUITE F1
LEESBURG, VA 20175 US
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Contact RICH WOODS
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Regulation Number 888.3060

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Classification Product Code MQP
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Date Received 06/02/2005
Decision Date 07/27/2005
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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