Identity
- Trade Name
- ELEOS™ FDA UDI
- Generic Name
- Body femoral/tibial extension stem, uncoated FDA UDI
- Device Name
- ELEOS™ SEGMENTAL STEM, CEMENTED STRAIGHT, FLUTED, 25MM COLLAR 11MM X 152MM FDA UDI
- Model / Reference
- 25000011E FDA UDI
- Description
- ELEOS™ SEGMENTAL STEM, CEMENTED STRAIGHT, FLUTED, 25MM COLLAR 11MM X 152MM FDA UDI
Identifiers
- Catalog Number
- 25000011E FDA UDI
- Primary DI / UDI-DI
- B27825000011E0 FDA UDI
- 510(k) Number
- K161520 FDA UDI
- FDA Product Code
- KRO FDA UDIJDI FDA UDI
- GMDN Term
- Body femoral/tibial extension stem, uncoated FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3510 FDA UDI888.3350 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
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Radiation Sterilization FDA UDI
Category: Body femoral/tibial extension stem, uncoated
Eleos™ by Onkos Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Body femoral/tibial extension stem, uncoated.
- Link OptiStem — WALDEMAR LINK GmbH & Co. KG · Class II
- Link OptiStem — WALDEMAR LINK GmbH & Co. KG · Class II
- Link OptiStem — WALDEMAR LINK GmbH & Co. KG · Class II
- Link OptiStem — WALDEMAR LINK GmbH & Co. KG · Class II
- Link OptiStem — WALDEMAR LINK GmbH & Co. KG · Class II
- Link OptiStem — WALDEMAR LINK GmbH & Co. KG · Class II
- iTotal® Identity Cruciate Retaining Knee Replacement System — Conformis, Inc. · Class II
- Link OptiStem — WALDEMAR LINK GmbH & Co. KG · Class II
Cleared under the same submission
K161520 also covers:
- ELEOS Limb Salvage System — ONKOS SURGICAL, INC.
- ELEOS™ — ONKOS SURGICAL, INC.
- ELEOS™ — ONKOS SURGICAL, INC.
- ELEOS™ — ONKOS SURGICAL, INC.
- ELEOS™ — ONKOS SURGICAL, INC.
- ELEOS™ — ONKOS SURGICAL, INC.
- ELEOS™ — ONKOS SURGICAL, INC.
- ELEOS™ — ONKOS SURGICAL, INC.
- ELEOS™ — ONKOS SURGICAL, INC.
- ELEOS™ — ONKOS SURGICAL, INC.
- ELEOS™ — ONKOS SURGICAL, INC.
- ELEOS™ — ONKOS SURGICAL, INC.
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 e0b87851-b509-473a-b109-137729fa3226 36 fields · synced May 30, 2026