FDA Registration
Active
🇺🇸 United States
S&N Unicompartmental & Bicompartmental Knee System Instruments
Reg #: 1828288
·
FEI: 1828288
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- ORCHID UNIQUE
- Registration Number
- 1828288
- FEI Number
- 1828288
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6688 Dixie Hwy
- City
- Bridgeport
- State
- MI
- ZIP
- 48722
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113038
Owner / Operator
- Firm Name
- Unique Instruments Inc.
- Operator Number
- 10042005
- Address
- 6688 Dixie Hwy
- City
- Bridgeport
- State
- MI
- Postal Code
- 48722
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2012-11-06 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2012-11-06 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2012-11-06 |
Proprietary Names
S&N Unicompartmental & Bicompartmental Knee System Instruments
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)