FDA Registration
Active
🇺🇸 United States
Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis
Reg #: 3010009693
·
FEI: 3010009693
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- rms Surgical
- Registration Number
- 3010009693
- FEI Number
- 3010009693
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1220 Lund Blvd
- City
- Anoka
- State
- MN
- ZIP
- 55303
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181947
Owner / Operator
- Firm Name
- THE CRETEX COMPANIES, INC.
- Operator Number
- 9001389
- Address
- 311 LOWELL AVE., --
- City
- Elk River
- State
- MN
- Postal Code
- 55330
- Country
- US
- Correspondent
- DARREN A KLATT
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2018-10-26 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2018-10-26 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2018-10-26 |
Proprietary Names
Knee Joint Patellofemorotibial Metal/Polymer Porous-Coated Uncemented Prosthesis
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)