FDA UDI
In Commercial Distribution
🇺🇸 United States
ELEOS™ Limb Salvage System
DI: B278CB1520003M0
·
Model: CB-15200-03M
·
ONKOS SURGICAL, INC.
Product Codes
2
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ELEOS™ Limb Salvage System
- Primary DI
- B278CB1520003M0
- Version / Model
- CB-15200-03M
- Catalog Number
- CB-15200-03M
- Company Name
- ONKOS SURGICAL, INC.
- Labeler DUNS
- 080254074
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2022-06-06
- Public Version
- 1
- Public Version Date
- 2022-06-14
- Public Version Status
- New
- Public Device Record Key
- 9a01c5e4-f5b2-4782-ab70-ebfa61bac864
Device Description
ELEOS Segmental Stem, Cemented, 15mm x 200mm, Bowed, Fluted, 32mm Collar
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- Yes
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- Yes
- Sterilization Methods
- Radiation Sterilization
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Orthopedic | 888.3350 | 2 |
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | Orthopedic | 888.3510 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 48066 | Knee femur stem prosthesis | A sterile device designed to provide additional stability for an implanted knee femur prosthesis by extending the attachment of the prosthesis from the distal femur into the midshaft of the bone. It is typically a shaft-like device made of metal [e.g., cobalt-chrome (Co-Cr)] and is often used in prosthesis revision to compensate for bone loss. | Yes | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B278CB1520003M0 | HIBCC |
Customer Contacts
- Phone
- +1(844)767-2766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K161520 | 000 |