FDA Registration
Active
🇺🇸 United States
OMNIPORE(R) Surgical Implant
Reg #: 3009383407
·
FEI: 3009383407
·
Expires 2025
Products
1
Proprietary Names
1
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
- K123908
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 |
|---|---|---|---|---|---|
| Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | KKY | Class 2 | General, Plastic Surgery | No | 2013-08-06 |
Proprietary Names
OMNIPORE(R) Surgical Implant
Establishment Types
Manufacture Medical Device