FDA 510(k) Application Details - K120143

Device Classification Name Intervertebral Fusion Device With Bone Graft, Cervical

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510(K) Number K120143
Device Name Intervertebral Fusion Device With Bone Graft, Cervical
Applicant APOLLO SPINE
128 Blye HIll Landing
Newbury, NH 03255 US
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Contact MICHELE LUCEY
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Regulation Number 888.3080

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Classification Product Code ODP
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Date Received 01/18/2012
Decision Date 02/16/2012
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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