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FDA 510(k) Application Details - K181079
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K181079
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
SeaSpine Orthopedics Corporation
5770 Armada Drive
Carlsbad, CA 92008 US
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Contact
Gina Flores
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
04/24/2018
Decision Date
07/18/2018
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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