FDA Registration
Active
🇺🇸 United States
Silverton
Reg #: 1835251
·
FEI: 3000205591
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- NGInstruments, Inc dba Avalign Cutting Instruments
- Registration Number
- 1835251
- FEI Number
- 3000205591
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4643 N State Road 15
- City
- Warsaw
- State
- IN
- ZIP
- 46582
- Country
- US
Regulatory Submissions
- 510(k) Number
- K120399
Owner / Operator
- Firm Name
- NG Instruments, Inc dba Avalign Cutting Instruments
- Operator Number
- 10042855
- Address
- 4643 North State Road 15
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- Country
- US
- Correspondent
- Heidi Funston
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-01-31 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2013-01-31 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-01-31 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-01-31 |
Proprietary Names
Silverton
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)