FDA Registration
Active
🇺🇸 United States
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Reg #: 3009888740
·
FEI: 3009888740
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Orchid Orthopedic Solutions Alabama LLC
- Registration Number
- 3009888740
- FEI Number
- 3009888740
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 331 City Park Dr SE
- City
- Arab
- State
- AL
- ZIP
- 35016
- Country
- US
Regulatory Submissions
- 510(k) Number
- K052906
Owner / Operator
- Firm Name
- Orchid Orhopedics
- Operator Number
- 10042268
- Address
- 331 City Park Dr. SE
- City
- Arab
- State
- AL
- Postal Code
- 35016
- Country
- US
- Correspondent
- Joel Roth
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2018-11-12 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2018-11-12 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2018-11-12 |
Proprietary Names
PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)