Identity
- Trade Name
- ELEOS™ FDA UDI
- Generic Name
- Femur/tibia shaft prosthesis FDA UDI
- Device Name
- ELEOS™ PROXIMAL FEMUR 98MM RESECTION FDA UDI
- Model / Reference
- 25000001E FDA UDI
- Description
- ELEOS™ PROXIMAL FEMUR 98MM RESECTION FDA UDI
Identifiers
- Catalog Number
- 25000001E FDA UDI
- Primary DI / UDI-DI
- B27825000001E0 FDA UDI
- 510(k) Number
- K161520 FDA UDI
- FDA Product Code
- JDI FDA UDIKRO FDA UDI
- GMDN Term
- Femur/tibia shaft prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3350 FDA UDI888.3510 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
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: Femur/tibia shaft prosthesis
Eleos™ by Onkos Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Femur/tibia shaft prosthesis.
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- CentLoc Total Knee System — RootLoc Co., Ltd. · Class II
- ORTHOPEDIC SALVAGE SYSTEM — Biomet Orthopedics, Inc. · 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 6b8dab02-1688-439f-a9f3-9a2b13f65a7f 36 fields · synced Jun 1, 2026