Not currently registered with FDA under this name
Stryker Leibinger
Kalamazoo, MI, United States. Named as applicant on 2 dental 510(k) clearances between 2000 and 2004. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22000–2004
- Markets registered in
- 327 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name Stryker Leibinger 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 | Stryker Leibinger | 2 clearances | 2000–2004 | Below |
| South Korea | MFDS | Manufacturer | Stryker LeibingerStryker Leibinger GmbH Co. KG | 25 | 2001–2013 | Pure Global AI |
| Canada | Health Canada | Registration holder | STRYKER LEIBINGER | 2 | 2000–2002 | 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 Stryker Leibinger as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 30 Sep 2004 | K041651 | STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM | DZE Root-Form Endosseous Implant |
| 8 Dec 2000 | K000594 | LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE | JEY Bone Plate |
Some of these clearances are listed with FDA today by another company: Stryker (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.