FDA Registration
Active
🇺🇸 United States
42583051401 Drill 42583053011 Reamer 42583053014 Reamer 42583057511 Reamer 42583057514 Reamer
Reg #: 1828288
·
FEI: 1828288
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
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
- K181947
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, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2018-11-06 |
Proprietary Names
42583051401 Drill 42583053011 Reamer 42583053014 Reamer 42583057511 Reamer 42583057514 Reamer
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)