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FDA 510(k) Application Details - K181471
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Cervical
More FDA Info for this Device
510(K) Number
K181471
Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Applicant
Absolute Advantage Medical, LLC
2731 Millbrook Road
Fayetteville, NC 78681 US
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Contact
J.D. Webb
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Regulation Number
888.3080
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Classification Product Code
ODP
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More FDA Info for this Product Code
Date Received
06/04/2018
Decision Date
08/29/2018
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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