FDA 510(k) Application Details - K243624

Device Classification Name	Washer, Bolt Nut   More FDA Info for this Device
510(K) Number	K243624
Device Name	Washer, Bolt Nut
Applicant	Acumed LLC 5885 NE Cornelious Pass Hillsboro, OR 97124 US Other 510(k) Applications for this Company
Contact	Marina Bull Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HTN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/25/2024
Decision Date	01/23/2025
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