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FDA 510(k) Application Details - K152302
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Cervical
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510(K) Number
K152302
Device Name
Intervertebral Fusion Device With Bone Graft, Cervical
Applicant
Xenco Medical, LLC
9930 Mesa Rim Road
San Diego, CA 92121 US
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Contact
Gustavo Prado
Other 510(k) Applications for this Contact
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
08/14/2015
Decision Date
09/10/2015
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Statement
Type
Special
Reviewed By Third Party
N
Expedited Review
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