FDA Registration
Active
🇺🇸 United States
Zimmer Persona Personalized Knee Medial Congruent Articular Surfaces
Reg #: 3005144609
·
FEI: 3005144609
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- EPTAM PLASTICS, LTD
- Registration Number
- 3005144609
- FEI Number
- 3005144609
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2 Riverside Business Park
- City
- Northfield
- State
- NH
- ZIP
- 03276
- Country
- US
Regulatory Submissions
- 510(k) Number
- K150090
Owner / Operator
- Firm Name
- EPTAM Plastics, Ltd
- Operator Number
- 10032547
- Address
- 2 Riverside Business Park
- City
- Northfield
- State
- NH
- Postal Code
- 03276
- Country
- US
- Correspondent
- Gerry LeBlanc
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 | 2018-07-11 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2018-07-11 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2018-07-11 |
Proprietary Names
Zimmer Persona Personalized Knee Medial Congruent Articular Surfaces
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)