FDA 510(k) Application Details - K250021

Device Classification Name	More FDA Info for this Device
510(K) Number	K250021
Device Name	Rotium
Applicant	Nanofiber Solutions, LLC 5164 Blazer Parkway Dublin, OH 43017 US Other 510(k) Applications for this Company
Contact	Jason Chakroff Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/03/2025
Decision Date	02/27/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review