Identity
- Trade Name
- ELEOS™ FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Reamer Trial 19.5x120MM FDA UDI
- Model / Reference
- RT-19500-03N FDA UDI
- Description
- Reamer Trial 19.5x120MM FDA UDI
Identifiers
- Catalog Number
- RT-19500-03N FDA UDI
- Primary DI / UDI-DI
- B278RT1950003N0 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
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: General internal orthopaedic fixation system implantation kit
ELEOS is a comprehensive internal orthopaedic fixation system implantation kit designed for the placement of various internal fixation systems into or onto bones, including limbs, spine, pelvis, and craniomaxillofacial. The device includes reusable instruments and devices intended for non-dedicated use, making it suitable for both in-clinic and in-office applications.
Similar devices
Also classified as General internal orthopaedic fixation system implantation kit.
- Matrixx System — NEXXT SPINE LLC · Class I
- Swedge Pedicle Screw Fixation System — SPINAL RESOURCES INC · Class II
- tangis — NVISION BIOMEDICAL TECHNOLOGIES, INC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ACUMED — ACUMED LLC · Class I
- OsteoMed — Osteomed Corp. · Class II
- ALEUTIAN® Interbody Systems — K2M, INC. · Class II
- HONOUR™ Spacer System — NEXXT SPINE LLC · 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
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 16612492-a60f-4d91-9fb7-aceaeed6d589 36 fields · synced Jul 29, 2026