FDA 510(k) Application Details - K231809

Device Classification Name	More FDA Info for this Device
510(K) Number	K231809
Device Name	Momentum« Posterior Spinal Fixation System with G21 V-STEADY Bone Cement; Momentum« MIS Posterior Spinal Fixation System with G21 V-STEADY Bone Cement
Applicant	Ulrich Medical USA 3700 E Plano Parkway Suite 200 Plano, TX 75074 US Other 510(k) Applications for this Company
Contact	Eric Lucas Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PML Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2023
Decision Date	10/20/2023
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