Identity
- Trade Name
- ELEOS™ FDA UDI
- Generic Name
- Bone-resection orthopaedic reamer, reusable FDA UDI
- Device Name
- CYLINDRICAL REAMER 17MM FDA UDI
- Model / Reference
- K0051017E FDA UDI
- Description
- CYLINDRICAL REAMER 17MM FDA UDI
Identifiers
- Catalog Number
- K0051017E FDA UDI
- Primary DI / UDI-DI
- B278K0051017E0 FDA UDI
- 510(k) Number
- K161520 FDA UDI
- FDA Product Code
- HWE FDA UDI
- GMDN Term
- Bone-resection orthopaedic reamer, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4820 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: Bone-resection orthopaedic reamer, reusable
Eleos™ by Onkos Surgical, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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 073e4a57-5aea-4e0c-88cf-05f852239935 36 fields · synced Jun 8, 2026