FDA 510(k) Application Details - K251296

Device Classification Name	More FDA Info for this Device
510(K) Number	K251296
Device Name	The Acumed Wrist Fixation System
Applicant	Acumed LLC 5885 NE Cornelius Pass Rd Hillsboro, OR 97124 US Other 510(k) Applications for this Company
Contact	Marina Bull Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/25/2025
Decision Date	06/18/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review