FDA Registration
Active
🇺🇸 United States
OMNIPORE DUROMAX ZB Orbital Implant
Reg #: 3009383407
·
FEI: 3009383407
·
Expires 2025
Products
1
Proprietary Names
2
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USA
- Registration Number
- 3009383407
- FEI Number
- 3009383407
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 98 Bledsoe Road
- City
- Newnan
- State
- GA
- ZIP
- 30265
- Country
- US
Regulatory Submissions
- 510(k) Number
- K180249
Owner / Operator
- Firm Name
- Matrix Surgical Holdings, LLC. dba Matrix Surgical USA
- Operator Number
- 10038239
- Address
- 98 Bledsoe Road
- City
- Newnan
- State
- GA
- Postal Code
- 30265
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plate, Bone | JEY | Class 2 | Dental | No | 2018-11-17 |
Proprietary Names
OMNIPORE DUROMAX ZB Orbital Implant
OMNIPORE DUROMAX Surgical Implants
Establishment Types
Manufacture Medical Device