FDA 510(k) Application Details - K151352

Device Classification Name Intervertebral Fusion Device With Bone Graft, Lumbar

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510(K) Number K151352
Device Name Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant MEDOS INTERNATIONAL SARL
CHEMIN-BLANC 38
LE LOCLE 2400 CH
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Contact JEFFREY SHIFFMAN
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Regulation Number 888.3080

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Classification Product Code MAX
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Date Received 05/20/2015
Decision Date 10/08/2015
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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