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FDA 510(k) Application Details - K173129
Device Classification Name
Rod, Fixation, Intramedullary And Accessories
More FDA Info for this Device
510(K) Number
K173129
Device Name
Rod, Fixation, Intramedullary And Accessories
Applicant
NuVasive Specialized Orthopedics, Inc.
101 Enterprise, Suite 100
Aliso Viejo, CA 92656 US
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Contact
Lance Justice
Other 510(k) Applications for this Contact
Regulation Number
888.3020
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Classification Product Code
HSB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2017
Decision Date
12/01/2017
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
OR - Orthopedic
Review Advisory Committee
OR - Orthopedic
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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