FDA 510(k) Application Details - K131540

Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar

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510(K) Number K131540
Device Name Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant VERTEBRAL TECHNOLOGIES, INC.
5909 Baker Road
Suite 550
Minnetonka, MN 55345 US
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Contact SURESH GHAI
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Regulation Number 888.3080

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Classification Product Code MAX
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Date Received 05/29/2013
Decision Date 09/03/2013
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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