FDA Registration
Active
🇺🇸 United States
ZMR Hip System
Reg #: 3006128100
·
FEI: 3006128100
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- Nemcomed FW LLC (d.b.a Avalign Instruments & Implants)
- Registration Number
- 3006128100
- FEI Number
- 3006128100
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 8727 & 8414 Clinton Park Dr
- City
- FORT WAYNE
- State
- IN
- ZIP
- 46825
- Country
- US
Regulatory Submissions
- 510(k) Number
- K113296
Owner / Operator
- Firm Name
- Avalign Instruments & Implants
- Operator Number
- 9008280
- Address
- 8727 Clinton Park Drive, --
- City
- Fort Wayne
- State
- IN
- Postal Code
- 46825
- Country
- US
- Correspondent
- Jeff Robinson
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2019-08-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2019-08-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2019-08-13 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2019-08-13 |
| Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer | KWZ | Class 2 | Orthopedic | No | 2019-08-13 |
Proprietary Names
ZMR Hip System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)