FDA Registration
Active
🇺🇸 United States
Medtronic IPC Powerease System
Reg #: 3006128100
·
FEI: 3006128100
·
Expires 2025
Products
7
Proprietary Names
1
Establishment Types
1
Classifications
7
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
- K143019
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 |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-05-28 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2024-05-28 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2024-05-28 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2024-05-28 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2024-05-28 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2024-05-28 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2024-05-28 |
Proprietary Names
Medtronic IPC Powerease System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)