FDA 510(k) Application Details - K181375

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K181375
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	OrthoXel Rubicon Center Cork Institute of Technology, Bishopstown Bishopstown T12 Y275 IE Other 510(k) Applications for this Company
Contact	Aisling O'Sullivan Other 510(k) Applications for this Contact
Regulation Number	888.3020   More FDA Info for this Regulation Number
Classification Product Code	HSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2018
Decision Date	07/17/2018
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