Not currently registered with FDA under this name
Medtronic Sofamor Danek
Memphis, TN, United States. Named as applicant on 5 dental 510(k) clearances between 2008 and 2009. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 52008–2009
- Markets registered in
- 8331 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 8 markets
Where regulators' registries name Medtronic Sofamor Danek 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 | Medtronic Sofamor Danek | 5 clearances | 2008–2009 | Below |
| United Kingdom | MHRA | Manufacturer | Medtronic Sofamor Danek Inc. | 287 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Medtronic Sofamor DanekMedtronic Sofamor Danek,Inc. | 28 | — | Pure Global AI |
| Colombia | INVIMA | Manufacturer | MEDTRONIC SOFAMOR DANEK | 8 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | MEDTRONIC SOFAMOR DANEK, INC. | 3 | 2013–2021 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | MEDTRONIC SOFAMOR DANEK INCMEDTRONIC SOFAMOR DANEK | 3 | 2014–2023 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Medtronic Sofamor Danek, Inc | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Medtronic Sofamor Danek | 1 | 2007–2007 | 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 Medtronic Sofamor Danek as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 9 Jan 2009 | K082917 | MASTERGRAFT RESORBABLE CERAMIC GRANULES | LYC Synthetic Bone Grafting Material |
| 10 Nov 2008 | K082463 | PROGENIX | NUN Human Source Bone Grafting Material |
| 17 Sep 2008 | K081784 | MASTERGRAFT PUTTY | LYC Synthetic Bone Grafting Material |
| 18 Jul 2008 | K081950 | PROGENIX PLUS | NUN Human Source Bone Grafting Material |
| 13 May 2008 | K080462 | PROGENIX DBM PUTTY | NUN Human Source Bone Grafting Material |
Some of these clearances are listed with FDA today by another company: Medtronic, Inc. (2).
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.