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FDA 510(k) Application Details - K140319
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K140319
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
NUVASIVE, INC.
7475 LUSK BLVD
SAN DIEGO, CA 92121 US
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Contact
JEREMY MARKOVICH
Other 510(k) Applications for this Contact
Regulation Number
888.3080
More FDA Info for this Regulation Number
Classification Product Code
MAX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
02/10/2014
Decision Date
10/09/2014
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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