FDA 510(k) Application Details - K242431

Device Classification Name	More FDA Info for this Device
510(K) Number	K242431
Device Name	Omnia Medical PsiF DNAÖ System
Applicant	Omnia Medical, LLC 6 Canyon Rd, Suite 300 Morgantown, WV 26508 US Other 510(k) Applications for this Company
Contact	Troy Schifano 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	08/16/2024
Decision Date	06/06/2025
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