FDA 510(k) Application Details - K251075

Device Classification Name	More FDA Info for this Device
510(K) Number	K251075
Device Name	DYNAMISÖ Implant System
Applicant	Promethean Restorative LLC 333 Perry Street, Suite 210 Castle Rock, CO 80104 US Other 510(k) Applications for this Company
Contact	Glenn Bowman 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	04/08/2025
Decision Date	04/25/2025
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