FDA 510(k) Application Details - K024364

Device Classification Name Spinal Vertebral Body Replacement Device

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510(K) Number K024364
Device Name Spinal Vertebral Body Replacement Device
Applicant SYNTHES (USA)
1690 RUSSELL RD.
PAOLI, PA 19301 US
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Contact JONATHAN GILBERT
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Regulation Number 888.3060

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Classification Product Code MQP
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Date Received 12/31/2002
Decision Date 03/17/2003
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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