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FDA 510(k) Application Details - K180373
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
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510(K) Number
K180373
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
Xenco Medical, LLC.
9930 Mesa Rim Road
San Diego, CA 92121 US
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Contact
Gustavo R. Prado
Other 510(k) Applications for this Contact
Regulation Number
888.3080
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Classification Product Code
MAX
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More FDA Info for this Product Code
Date Received
02/12/2018
Decision Date
08/24/2018
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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