FDA 510(k) Application Details - K181818

Device Classification Name	More FDA Info for this Device
510(K) Number	K181818
Device Name	Scarlet AL-T
Applicant	Spineart 3 Chemin du PrΘ Fleuri Plan Les Ouates 1228 CH Other 510(k) Applications for this Company
Contact	Franck Pennesi Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OVD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/09/2018
Decision Date	10/09/2018
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