FDA Registration
Active
🇺🇸 United States
Avalign Delivery Systems Division
Reg #: 1835444
·
FEI: 3000717687
·
Expires 2025
Products
1
Proprietary Names
0
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Avalign Delivery Systems Division
- Registration Number
- 1835444
- FEI Number
- 3000717687
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2121 SOUTHTECH DRIVE, SUITE 600
- City
- Greenwood
- State
- IN
- ZIP
- 46143
- Country
- US
Regulatory Submissions
- 510(k) Number
- K140879
Owner / Operator
- Firm Name
- Avalign Delivery Systems Division
- Operator Number
- 9026184
- Address
- 2121 Southtech Drive, Suite 600
- City
- Greenwood
- State
- IN
- Postal Code
- 46143
- Country
- US
- Correspondent
- Thomas Clyne
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2016-05-16 |
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)