FDA Registration
Active
🇺🇸 United States
Zimmer Persona Personalized Knee System
Reg #: 2244478
·
FEI: 1000136269
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Cosmed Group, Inc., d/b/a Cosmed of NJ
- Registration Number
- 2244478
- FEI Number
- 1000136269
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 19 PARK DR.
- City
- Franklin
- State
- NJ
- ZIP
- 07416
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172524
Owner / Operator
- Firm Name
- Cosmed Group, Inc.
- Operator Number
- 2244478
- Address
- 28 Narragansett Ave.
- City
- Jamestown
- State
- RI
- Postal Code
- 02835
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | Class 2 | Orthopedic | No | 2021-05-11 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | Class 2 | Orthopedic | No | 2021-05-11 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2021-05-11 |
Proprietary Names
Zimmer Persona Personalized Knee System
Establishment Types
Sterilize Medical Device for Another Party (Contract Sterilizer)