FDA Registration
Active
🇺🇸 United States
InterOss
Reg #: 3009598981
·
FEI: 3009598981
·
Expires 2025
Products
1
Proprietary Names
4
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SIGMAGRAFT, INC.
- Registration Number
- 3009598981
- FEI Number
- 3009598981
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 575 Sally Pl
- City
- Fullerton
- State
- CA
- ZIP
- 92831
- Country
- US
Regulatory Submissions
- 510(k) Number
- K151209
Owner / Operator
- Firm Name
- SigmaGraft, Inc.
- Operator Number
- 10040723
- Address
- 575 Sally Place
- City
- Fullerton
- State
- CA
- Postal Code
- 92831
- Country
- US
- Correspondent
- Dae Kyu Chang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Grafting Material, Animal Source | NPM | Class 2 | Dental | No | 2015-11-16 |
Proprietary Names
InterOss
Mega-Oss BovineTM
Maxxeus Dental Xenograft Particulates
Maxxeus
Establishment Types
Manufacture Medical Device