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 MODULAR COLLAR LOCKING RING AND IMPACTOR TIP FDA UDI
Model / Reference: HR-30001-03M FDA UDI
Description: ELEOS MODULAR COLLAR LOCKING RING AND IMPACTOR TIP FDA UDI

Identifiers

Catalog Number: HR-30001-03M FDA UDI
Primary DI / UDI-DI: B278HR3000103M0 FDA UDI
FDA Product Code: JWH FDA UDI
JDI FDA UDI
KRO FDA UDI
KWY FDA UDI
LPH FDA UDI
LZO FDA UDI
GMDN Term: Knee femur stem prosthesis FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3560 FDA UDI
888.3350 FDA UDI
888.3510 FDA UDI
888.3390 FDA UDI
888.3358 FDA UDI
888.3353 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

Yes

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Coated hip femur prosthesis, modular 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

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Onkos Surgical, Inc.

Sources (1)

FDA UDI be561b8d-f9ad-4da3-a0b8-5c8af0a726f7 35 fields · synced Jun 1, 2026