510(k) K253066

Device: ELEOS™ with NanoCept® Technology Limb Salvage System
Applicant: Onkos Surgical, Inc.
510(k) number: K253066
Product code: QZZ
Decision: Substantially Equivalent (SESE)
Decision date: 2026-06-08
Date received: 2025-09-22
Regulation: 888.3900
Classification name: Limb And Joint Salvage Device With Coating For Bacteria Reduction
Medical specialty: Orthopedic
Review panel: Orthopedic
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: N

Applicant Contact#

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K252920	ELEOS™ Limb Salvage System with NanoCept® Technology	Onkos Surgical, Inc.	2025-10-15
DEN210058	ELEOSx™ Limb Salvage System	Onkos Surgical	2024-04-05