FDA 510(k) Application Details - DEN210058

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN210058
Device Name	ELEOSxÖ Limb Salvage System
Applicant	Onkos Surgical 77 East Halsey Rd Parsippany, NJ 07054 US Other 510(k) Applications for this Company
Contact	Matthew (Matt) Vernak Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	QZZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/30/2021
Decision Date	04/05/2024
Decision	DENG -
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Direct
Reviewed By Third Party	N
Expedited Review