FDA 510(k) Application Details - K062933

Device Classification Name Spinal Vertebral Body Replacement Device

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510(K) Number K062933
Device Name Spinal Vertebral Body Replacement Device
Applicant SYNTHES SPINE CO.LP
1302 WRIGHTS LANE EAST
WEST CHESTER, PA 19380 US
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Contact BONNIE J SMITH
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Regulation Number 888.3060

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Classification Product Code MQP
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Date Received 09/28/2006
Decision Date 01/31/2007
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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