ELEOS™ Limb Salvage System

FDA UDI

Class II (US FDA UDI)

by Onkos Surgical, Inc.

Identity

Trade Name: ELEOS™ Limb Salvage System FDA UDI
Generic Name: Uncoated knee tibia/insert prosthesis FDA UDI
Device Name: ELEOS™ Resurfacing Femur, Size 3, Right FDA UDI
Model / Reference: RF-R003E-01M FDA UDI
Description: ELEOS™ Resurfacing Femur, Size 3, Right FDA UDI

Identifiers

Catalog Number: RF-R003E-01M FDA UDI
Primary DI / UDI-DI: B278RFR003E01M0 FDA UDI
FDA Product Code: KRO FDA UDI
GMDN Term: Uncoated knee tibia/insert prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3510 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Dimensions & Sizes

Size: Width — 65 Millimeter FDA UDI

Category: Uncoated knee tibia/insert prosthesis

ELEOS™ Limb Salvage System by Onkos Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Uncoated knee tibia/insert prosthesis.

Arthrex® — Arthrex, Inc. · Class II
Vanguard Complete Knee System — Biomet Orthopedics, Inc. · Class II
Arthrex® — Arthrex, Inc. · Class II
LOSPA Total Knee System — Corentec Co., Ltd · Class II
LOSPA Total Knee System — Corentec Co., Ltd · Class II
LOSPA Modular Knee System — Corentec Co., Ltd · Class II
Arthrex® — Arthrex, Inc. · Class II
LOSPA Modular Knee System — Corentec Co., Ltd · Class II

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Onkos Surgical, Inc.

Sources (1)

FDA UDI d5626990-4f5e-41e5-a27f-15e181338a65 36 fields · synced Jun 8, 2026