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FDA 510(k) Application Details - K173025
Device Classification Name
Intervertebral Fusion Device With Bone Graft, Lumbar
More FDA Info for this Device
510(K) Number
K173025
Device Name
Intervertebral Fusion Device With Bone Graft, Lumbar
Applicant
NuVasive, Incorporated
7475 Lusk Blvd.
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact
Cynthia Adams
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
09/28/2017
Decision Date
02/08/2018
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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