FDA Registration
Active
🇺🇸 United States
Trivicta
Reg #: 3011277306
·
FEI: 3011277306
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- Orchid Detroit
- Registration Number
- 3011277306
- FEI Number
- 3011277306
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 23149 Commerce Drive
- City
- Farmington Hills
- State
- MI
- ZIP
- 48335
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233758
Owner / Operator
- Firm Name
- CEP Bio-Coat, LLC D/B/A Orchid Orthopedic Solutions, LLC
- Operator Number
- 10042681
- Address
- 23149 Commerce Dr
- City
- Farmington Hills
- State
- MI
- Postal Code
- 48335
- Country
- US
- Correspondent
- Ray Maroofian
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate | MEH | Class 2 | Orthopedic | No | 2024-12-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2024-12-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2024-12-13 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | Class 2 | Orthopedic | No | 2024-12-13 |
Proprietary Names
Trivicta
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)