FDA Registration
Active
🇺🇸 United States
iBalance TKA System - CR Plus Tibial Bearing
Reg #: 3009882462
·
FEI: 3009882462
·
Expires 2025
Products
2
Proprietary Names
1
Establishment Types
1
Classifications
2
Registration Details
- Registration Name
- PERRYMAN COMPANY
- Registration Number
- 3009882462
- FEI Number
- 3009882462
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 149 S Johnson Rd
- City
- Houston
- State
- PA
- ZIP
- 15342
- Country
- US
Regulatory Submissions
- 510(k) Number
- K152382
Owner / Operator
- Firm Name
- Perryman Company
- Operator Number
- 10042198
- Address
- 149 South Johnson Rd
- City
- Houston
- State
- PA
- Postal Code
- 15342
- Country
- US
- Correspondent
- Dylan Crawford
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 | 2022-02-25 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2022-02-25 |
Proprietary Names
iBalance TKA System - CR Plus Tibial Bearing
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)