meddevicedb.com FDA Device Reference

ELEOSx™ Limb Salvage System

DEN210058 Class II Direct
Decision Date
2024-04-05
Sponsor / Applicant
Onkos Surgical

Technical Specification

510(k) Submission ID DEN210058
Product Code QZZ
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3900
Decision Date 2024-04-05
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

ELEOSx™ Limb Salvage System received FDA 510(k) clearance under submission number DEN210058, sponsored by Onkos Surgical. The device was reviewed via the Direct premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2024-04-05.

Classification & Regulation

This clearance is catalogued under FDA product code QZZ and 21 CFR 888.3900, within the Orthopedic review panel as a Class II device.