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: Knee femur stem prosthesis FDA UDI
Device Name: ELEOS Segmental Stem, Cemented, 17mm x 200mm, Bowed, Fluted, 36mm Collar FDA UDI
Model / Reference: CB-17200-03M FDA UDI
Description: ELEOS Segmental Stem, Cemented, 17mm x 200mm, Bowed, Fluted, 36mm Collar FDA UDI

Identifiers

Catalog Number: CB-17200-03M FDA UDI
Primary DI / UDI-DI: B278CB1720003M0 FDA UDI
510(k) Number: K161520 FDA UDI
FDA Product Code: KRO FDA UDI
JDI FDA UDI
GMDN Term: Knee femur stem prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3510 FDA UDI
888.3350 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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Knee femur stem 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 Knee femur stem prosthesis.

Endo-Model Standard Knee Prosthesis System — WALDEMAR LINK GmbH & Co. KG · Class II
Biomet Knee System — Biomet Orthopedics, Inc. · Class II
Unity Total Knee System — CORIN LTD · Class II
LINK Endo-Model EVO — WALDEMAR LINK GmbH & Co. KG · Class II
OPTILOCK PERIARTICULAR PLATING SYSTEM — Biomet Orthopedics, Inc. · Class II
Evolution Revision CCK System — MicroPort Orthopedics Inc. · Class II
Modular Stem, — WALDEMAR LINK GmbH & Co. KG · Class II
LINK Endo-Model EVO Knee System — WALDEMAR LINK GmbH & Co. KG · Class II

Cleared under the same submission

K161520 also covers:

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 3d252506-45af-42ad-aeaf-821175e69266 36 fields · synced Jun 8, 2026