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FDA 510(k) Application Details - K191500
Device Classification Name
Appliance, Fixation, Spinal Intervertebral Body
More FDA Info for this Device
510(K) Number
K191500
Device Name
Appliance, Fixation, Spinal Intervertebral Body
Applicant
NuVasive, Incorporated
7475 Lusk Blvd.
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact
Jessica Silverman
Other 510(k) Applications for this Contact
Regulation Number
888.3060
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Classification Product Code
KWQ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/06/2019
Decision Date
09/03/2019
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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