FDA 510(k) Application Details - K243173

Device Classification Name	More FDA Info for this Device
510(K) Number	K243173
Device Name	Salto Talaris Ankle PSI System
Applicant	3D Systems, Inc. 5381 South Alkire Circle Littleton, CO 80127 US Other 510(k) Applications for this Company
Contact	Ashley Dawson Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OYK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/30/2024
Decision Date	10/25/2024
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