FDA 510(k) Application Details - K241321

Device Classification Name	More FDA Info for this Device
510(K) Number	K241321
Device Name	Juliet« Ti LL Lumbar Interbody Device
Applicant	Spineart SA 3 Chemin Du PrΘ-Fleuri Plan Les Ouates 1228 CH Other 510(k) Applications for this Company
Contact	Estelle Lefeuvre 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	05/10/2024
Decision Date	07/18/2024
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