FDA 510(k) Application Details - K243955

Device Classification Name	More FDA Info for this Device
510(K) Number	K243955
Device Name	Precision AI Surgical Planning System (PAI-SPS)
Applicant	Precision AI Pty Ltd Address Suite 18, 36 Agnes Street Fortitude Valley AU Other 510(k) Applications for this Company
Contact	Sara Baniadam Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QHE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2024
Decision Date	01/21/2025
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