FDA Registration
Active
🇺🇸 United States
ELEOS
Reg #: 3013450937
·
FEI: 3013450937
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
2
Classifications
5
Registration Details
- Registration Name
- ONKOS SURGICAL, INC.
- Registration Number
- 3013450937
- FEI Number
- 3013450937
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 77 E HALSEY RD
- City
- Parsippany
- State
- NJ
- ZIP
- 07054
- Country
- US
Regulatory Submissions
- 510(k) Number
- K161520
Owner / Operator
- Firm Name
- Onkos Surgical
- Operator Number
- 10054049
- Address
- 77 East Halsey Rd
- City
- Parsippany
- State
- NJ
- Postal Code
- 07054
- Country
- US
- Correspondent
- Len Tokish
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2017-02-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2017-02-06 |
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2017-02-06 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2017-02-06 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2017-02-06 |
Proprietary Names
ELEOS
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility