FDA 510(k) Application Details - K073202

Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar

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510(K) Number K073202
Device Name Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant ABBOTT SPINE, INC.
5301 RIATA PARK CT., BLDG F
AUSTIN, TX 78727 US
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Contact MARITZA ELIAS
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Regulation Number 888.3080

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Classification Product Code MAX
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Date Received 11/13/2007
Decision Date 01/30/2008
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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