FDA Registration
Active
🇺🇸 United States
ELEOS Limb Salvage System with BioGrip
Reg #: 3014252644
·
FEI: 3014252644
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- C&A Tool Engineering, Inc. Auburn Plant
- Registration Number
- 3014252644
- FEI Number
- 3014252644
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1015 W 15th St
- City
- Auburn
- State
- IN
- ZIP
- 46706
- Country
- US
Regulatory Submissions
- 510(k) Number
- K203815
Owner / Operator
- Firm Name
- MinebeaMitsumi Inc.
- Operator Number
- 10055758
- Address
- 3-9-6 Mita
- City
- Minato-ku
- State
- Tokyo
- Postal Code
- 108-8330
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | KRO | Class 2 | Orthopedic | No | 2022-12-08 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2022-12-08 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2022-12-08 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | Class 2 | Orthopedic | No | 2022-12-08 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2022-12-08 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2022-12-08 |
Proprietary Names
ELEOS Limb Salvage System with BioGrip
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)