FDA 510(k) Application Details - K130630

Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar

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510(K) Number K130630
Device Name Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant LIFE SPINE, INC
2401 W. HASSELL RD SUITE 1535
HOFFMAN ESTATES, IL 60169 US
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Contact RANDY LEWIS
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Regulation Number 888.3080

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Classification Product Code MAX
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Date Received 03/08/2013
Decision Date 06/13/2013
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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