FDA 510(k) Application Details - K091426

Device Classification Name Spinal Vertebral Body Replacement Device

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510(K) Number K091426
Device Name Spinal Vertebral Body Replacement Device
Applicant VERTICOR, LTD
1001 OAKWOOD BLVD.
ROUND ROCK, TX 78681 US
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Contact J.D. WEBB
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Regulation Number 888.3060

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Classification Product Code MQP
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Date Received 05/13/2009
Decision Date 12/23/2009
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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