FDA 510(k)

ELEOS Limb Salvage System

K-Number: K203588 · 2021-02-05

Decision Date2021-02-05

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

ELEOS Limb Salvage System is a medical device manufactured by Onkos Surgical. It received FDA 510(k) clearance on 2021-02-05 under approval number K203588. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELEOS Limb Salvage System?

ELEOS Limb Salvage System is a medical device that received FDA 510(k) clearance on 2021-02-05. It is manufactured by Onkos Surgical. The 510(k) number is K203588.

When was ELEOS Limb Salvage System approved by the FDA?

ELEOS Limb Salvage System received FDA 510(k) clearance on 2021-02-05, under approval number K203588.

What company makes ELEOS Limb Salvage System?

ELEOS Limb Salvage System is manufactured by Onkos Surgical.

What is the FDA product code for ELEOS Limb Salvage System?

The FDA product code for ELEOS Limb Salvage System is JDI.

Other Devices by Onkos Surgical

K203090ELEOS Limb Salvage System featuring BIOGRIP K211677ELEOS Limb Salvage System K203815ELEOS Limb Salvage System with BioGrip K212815My3D® Personalized Pelvic Reconstruction DEN210058ELEOSx Limb Salvage System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.