Manufacturer registered with FDA
Matrix Surgical Holdings, LLC. dba Matrix Surgical USA
Newnan, GA, United States. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
Registered in 2 markets
Where regulators' registries name Matrix Surgical Holdings, LLC. dba Matrix Surgical USA as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Matrix Surgical Holdings, LLC. dba Matrix Surgical USA | 1 device types | — | Below |
| Taiwan | TFDA | Manufacturer | Matrix Surgical Holdings, LLC dba Matrix Surgical USA | 1 | 2016–2016 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Matrix Surgical Holdings, LLC. dba Matrix Surgical USA currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | OMNIPORE DUROMAX Surgical ImplantsOMNIPORE DUROMAX ZB Orbital Implant | 2018 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Matrix Surgical Holdings, LLC. dba Matrix Surgical USA lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Matrix Surgical Holdings, LLC/Matrix Surgical USA (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 11 Oct 2018 | K180249 | OmniPore DUROMAX Surgical Implants | Matrix Surgical Holdings, LLC/Matrix Surgical USA | JEY Bone Plate |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MATRIX SURGICAL HOLDINGS, LLC dba MATRIX SURGICAL USAFDA reg. 3009383407 | Newnan, GA, United States | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10038239). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.