FDA 510(k) Application Details - K181630

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component   More FDA Info for this Device
510(K) Number	K181630
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant	New Standard Device DBA Metalogix 4766 Research Drive San Antonio, TX 78240 US Other 510(k) Applications for this Company
Contact	Bryant Phamvu Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	KTT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2018
Decision Date	05/29/2019
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