FDA Registration
Active
🇺🇸 United States
Comprehensive Shoulder
Reg #: 1828288
·
FEI: 1828288
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
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
- K140390
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, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2020-01-15 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2020-01-15 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2020-01-15 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2020-01-15 |
Proprietary Names
Comprehensive Shoulder
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)