FDA 510(k) Application Details - K233241

Device Classification Name	More FDA Info for this Device
510(K) Number	K233241
Device Name	SOLACE Sacroiliac Fixation System
Applicant	HT Medical LLC dba Xenix Medical 111 W Jefferson St Suite 100 Orlando, FL 32801 US Other 510(k) Applications for this Company
Contact	Teresa Cherry 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	09/28/2023
Decision Date	10/27/2023
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