FDA Registration
Active
🇺🇸 United States
JOURNEY II XR Knee System
Reg #: 3005852519
·
FEI: 3005852519
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ORCHID ORTHOPEDIC SOLUTIONS LANSING
- Registration Number
- 3005852519
- FEI Number
- 3005852519
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1489 CEDAR ST.
- City
- HOLT
- State
- MI
- ZIP
- 48842
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152726
Owner / Operator
- Firm Name
- ORCHID ORTHOPEDIC SOLUTIONS LLC
- Operator Number
- 9085942
- Address
- 1489 CEDAR ST., --
- City
- Holt
- State
- MI
- Postal Code
- 48842
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2018-03-07 |
Proprietary Names
JOURNEY II XR Knee System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)