FDA Registration
Active
🇺🇸 United States
Escalade Legend Acetabular Shell
Reg #: 3009888740
·
FEI: 3009888740
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
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
- K161080
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, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2020-10-21 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2020-10-21 |
Proprietary Names
Escalade Legend Acetabular Shell
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)