Not currently registered with FDA under this name
Howmedica Leibinger, Inc.
Rutherford, NJ, United States. Named as applicant on 6 dental 510(k) clearances between 1996 and 1997. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 61996–1997
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 1990–2026
510(k) clearances
Clearances on which FDA names Howmedica Leibinger, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 11 Aug 1997 | K972166 | GUERRERO - BELL DISTRACTOR | JEY Bone Plate |
| 11 Aug 1997 | K972154 | COHEN DISTRACTOR | JEY Bone Plate |
| 11 Apr 1997 | K970911 | LEE PLATE | JEY Bone Plate |
| 11 Apr 1997 | K963030 | LEIBINGER IMF SCREW | DZE Root-Form Endosseous Implant |
| 24 Jan 1997 | K964649 | VAZQUEZ DINER INTRAORAL DISTRACTION DEVICE | JEY Bone Plate |
| 28 Oct 1996 | K963740 | LEIBINGER - LUHR SMALL MANDIBULAR BONE SCREWS | 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.