FDA 510(k) Application Details - K070382

Device Classification Name Spinal Vertebral Body Replacement Device

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510(K) Number K070382
Device Name Spinal Vertebral Body Replacement Device
Applicant ZIMMER TRABECULAR METAL TECHNOLOGY
10 POMEROY RD.
PARSIPPANY, NJ 07054 US
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Contact JENNIFER P HARAKAL
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Regulation Number 888.3060

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Classification Product Code MQP
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Date Received 02/08/2007
Decision Date 05/30/2007
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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