FDA 510(k) Application Details - K083661

Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar

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510(K) Number K083661
Device Name Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant STRYKER CORP.
2 PEARL COURT
ALLENDALE, NJ 07401 US
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Contact KIMBERLY LANE
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Regulation Number 888.3080

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Classification Product Code MAX
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Date Received 12/10/2008
Decision Date 02/27/2009
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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