FDA Registration
Active
🇺🇸 United States
Agility Symmetric Total Knee System
Reg #: 3004986960
·
FEI: 3004986960
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- Medisurge
- Registration Number
- 3004986960
- FEI Number
- 3004986960
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2140 Oak Industrial Dr. NE
- City
- Grand Rapids
- State
- MI
- ZIP
- 49505
- Country
- US
Regulatory Submissions
- 510(k) Number
- K242412
Owner / Operator
- Firm Name
- Medisurge
- Operator Number
- 9068542
- Address
- 2140 Oak Industrial Dr NE, --
- City
- Grand Rapids
- State
- MI
- Postal Code
- 49505
- Country
- US
- Correspondent
- Megan M Morrissey
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 | 2025-01-03 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2025-01-03 |
Proprietary Names
Agility Symmetric Total Knee System
Establishment Types
Manufacture Medical Device