FDA Registration
Active
🇺🇸 United States
EluPro Antibiotic-Eluting BioEnvelope
Reg #: 3005619880
·
FEI: 3005619880
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- Elutia Inc.
- Registration Number
- 3005619880
- FEI Number
- 3005619880
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1100 Old Ellis Rd, Suite 1200
- City
- Roswell
- State
- GA
- ZIP
- 30076
- Country
- US
Regulatory Submissions
- 510(k) Number
- K233991
Owner / Operator
- Firm Name
- Elutia Inc.
- Operator Number
- 10055257
- Address
- 1100 Old Ellis Road, Suite 1200
- City
- Roswell
- State
- GA
- Postal Code
- 30076
- Country
- US
- Correspondent
- Mike Hennick
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2024-09-04 |
| Mesh, Surgical | FTM | Class 2 | General, Plastic Surgery | No | 2024-09-04 |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | Class 2 | General, Plastic Surgery | No | 2024-09-04 |
| Collagen Surgical Mesh Containing Drugs | PIJ | Class 2 | General, Plastic Surgery | No | 2024-09-04 |
Proprietary Names
EluPro Antibiotic-Eluting BioEnvelope
Establishment Types
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198