FDA 510(k) Application Details - K191212

Device Classification Name	More FDA Info for this Device
510(K) Number	K191212
Device Name	CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System,
Applicant	Medos International SARL Chemin-Blanc 38 Le Locle 2400 CH Other 510(k) Applications for this Company
Contact	Sergio M. Cordeiro Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PGM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/06/2019
Decision Date	09/24/2019
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