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: Body femoral/tibial extension stem, uncoated FDA UDI
Device Name: ELEOS SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 36MM COLLAR, 21MM X 152MM FDA UDI
Model / Reference: FB-21152-03M FDA UDI
Description: ELEOS SEGMENTAL STEM, CANAL FILLING, BOWED, SLOTTED, SPLINED, 2/3 PLASMA, 36MM COLLAR, 21MM X 152MM FDA UDI

Identifiers

Catalog Number: FB-21152-03M FDA UDI
Primary DI / UDI-DI: B278FB2115203M0 FDA UDI
510(k) Number: K161520 FDA UDI
FDA Product Code: JDI FDA UDI
KRO FDA UDI
GMDN Term: Body femoral/tibial extension stem, uncoated FDA UDI

Classification

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

Yes

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Category: Body femoral/tibial extension stem, uncoated

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

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Also classified as Body femoral/tibial extension stem, uncoated.

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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 4a1c9b5c-c623-451e-b6df-455f5264f674 36 fields · synced Jun 8, 2026