Identity
- Trade Name
- ELEOS™ FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- TRIAL BLOCK AUGMENT 15MM, SIZE 1 FDA UDI
- Model / Reference
- K0053037E FDA UDI
- Description
- TRIAL BLOCK AUGMENT 15MM, SIZE 1 FDA UDI
Identifiers
- Catalog Number
- K0053037E FDA UDI
- Primary DI / UDI-DI
- B278K0053037E0 FDA UDI
- 510(k) Number
- K161520 FDA UDI
- FDA Product Code
- HWT FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General internal orthopaedic fixation system implantation kit
Eleos™ by Onkos Surgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as General internal orthopaedic fixation system implantation kit.
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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 I | Pending data |
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Manufacturer
- Manufacturer
- Onkos Surgical, Inc.
Sources (1)
- FDA UDI cc420600-f84b-43e1-aa7e-787dfafda3b5 36 fields · synced May 30, 2026