FDA 510(k) Application Details - K250247

Device Classification Name	More FDA Info for this Device
510(K) Number	K250247
Device Name	panaSIa SI Fusion System
Applicant	Wenzel Spine, Inc. 2535 Brockton Drive Suite 450 Austin, TX 78758 US Other 510(k) Applications for this Company
Contact	William Wilson 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	01/27/2025
Decision Date	07/09/2025
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