FDA 510(k) Application Details - K191241

Device Classification Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component   More FDA Info for this Device
510(K) Number	K191241
Device Name	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Applicant	OrthoSpin 17 Hatechelet Street Misgav 2017400 IL Other 510(k) Applications for this Company
Contact	Oren Cohen 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	05/08/2019
Decision Date	08/14/2019
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