FDA 510(k) Application Details - K052950

Device Classification Name Spinal Vertebral Body Replacement Device

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510(K) Number K052950
Device Name Spinal Vertebral Body Replacement Device
Applicant ZIMMER TRABECULAR
80 COMMERCE DR.
ALLENDALE, NJ 07401 US
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Contact MARCI HALEVI
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Regulation Number 888.3060

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Classification Product Code MQP
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Date Received 10/20/2005
Decision Date 11/16/2005
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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