FDA 510(k) Application Details - K232605

Device Classification Name	More FDA Info for this Device
510(K) Number	K232605
Device Name	Sacrix« Sacroiliac Joint Fusion Device System, Inspan« ScrewLES Fusion System, Invue« MAXÖ + Invue Inset Anterior Cervical Plate System, and FacetFuse« Screw Fixation System
Applicant	LESspine Innovations 350 Main St Malden, MA 02148 US Other 510(k) Applications for this Company
Contact	Vito Lore Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OUR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/28/2023
Decision Date	09/28/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review