FDA Registration
Active
🇺🇸 United States
Restoris MCK Implant System
Reg #: 1827096
·
FEI: 1827096
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- ORCHID ORTHOPEDICS-CHELSEA
- Registration Number
- 1827096
- FEI Number
- 1827096
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 13800 Luick Dr
- City
- Chelsea
- State
- MI
- ZIP
- 48118
- Country
- US
Regulatory Submissions
- 510(k) Number
- K090763
Owner / Operator
- Firm Name
- Orchid Orthopedic Solutions
- Operator Number
- 10042895
- Address
- 13800 Luick Drive
- City
- Chelsea
- State
- MI
- Postal Code
- 48118
- Country
- US
- Correspondent
- Albert A DeWalt
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2017-09-01 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2017-09-01 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2017-09-01 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2017-09-01 |
Proprietary Names
Restoris MCK Implant System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)