FDA 510(k) Application Details - K090707

Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar

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510(K) Number K090707
Device Name Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant MEDITECH ADVISORS, LLC
950 N. MICHIGAN AVE.
SUITE 2202
CHICAGO, IL 60611 US
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Contact JANET M WEBB
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Regulation Number 888.3080

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Classification Product Code MAX
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Date Received 03/17/2009
Decision Date 07/15/2009
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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