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FDA 510(k) Application Details - K172979
Device Classification Name
More FDA Info for this Device
510(K) Number
K172979
Device Name
NuVasive« Growth Rod Conversion Set
Applicant
NuVasive, Incorporated
7475 Lusk Boulevard
San Diego, CA 92121 US
Other 510(k) Applications for this Company
Contact
Olga Lewis
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PGM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/27/2017
Decision Date
11/06/2017
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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