FDA 510(k) Application Details - K071497

Device Classification Name Spinal Vertebral Body Replacement Device

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510(K) Number K071497
Device Name Spinal Vertebral Body Replacement Device
Applicant ATLAS SPINE INC.
1555 JUPITER PARK DR., STE. 4
JUPITER, FL 33458 US
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Contact JEANNETTE G DAILEY
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Regulation Number 888.3060

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Classification Product Code MQP
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Date Received 05/31/2007
Decision Date 06/29/2007
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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