FDA 510(k) Application Details - K990148

Device Classification Name Spinal Vertebral Body Replacement Device

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510(K) Number K990148
Device Name Spinal Vertebral Body Replacement Device
Applicant DEPUY MOTECH ACROMED
325 PARAMOUNT DR.
RAYHAM, MA 02767-0350 US
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Contact WILLIAM CHRISTIANSON
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Regulation Number 888.3060

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Classification Product Code MQP
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Date Received 01/19/1999
Decision Date 09/03/1999
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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