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FDA 510(k) Application Details - K192181
Device Classification Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
More FDA Info for this Device
510(K) Number
K192181
Device Name
Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant
NuVasive Specialized Orthopedics, Inc.
101 Enterprise, Suite 100
Aliso Viejo, CA 92656 US
Other 510(k) Applications for this Company
Contact
Madison Heffron
Other 510(k) Applications for this Contact
Regulation Number
888.3030
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Classification Product Code
KTT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/12/2019
Decision Date
11/07/2019
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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