Not currently registered with FDA under this name
Sofamor Danek USA,Inc.
Memphis, TN, United States. Named as applicant on 1 dental 510(k) clearance between 1997 and 1997. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 11997–1997
- Markets registered in
- 22 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Sofamor Danek USA,Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Sofamor Danek USA,Inc. | 1 clearances | 1997–1997 | Below |
| South Korea | MFDS | Manufacturer | Sofamor Danek USA | 2 | 1999–2000 | 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
510(k) clearances
Clearances on which FDA names Sofamor Danek USA,Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 19 Nov 1997 | K973145 | TIMESH TITANIUM MINI-SOFTPLATE AND MICRO-SOFT PLATE/SCREW SYSTEM | JEY Bone Plate |
Some of these clearances are listed with FDA today by another company: Medtronic, Inc. (1).
Sources
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 of the most recent filing, which can be a US agent.