Not currently registered with FDA under this name
Macropore Biosurgery, Inc.
San Diego, CA, United States. Named as applicant on 4 dental 510(k) clearances between 2000 and 2001. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 42000–2001
- Markets registered in
- 1United States
- Establishments
- 0—
510(k) clearances per year, 2000–2026
510(k) clearances
Clearances on which FDA names Macropore Biosurgery, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 18 Sep 2001 | K012413 | MACROPORE FX, PS, NS, LP | JEY Bone Plate |
| 11 Jul 2001 | K002207 | MACROPOREPX PEDIATRIC SYSTEM | JEY Bone Plate |
| 19 Oct 2000 | K000696 | MACROPOREMX MANDIBULAR FIXATION SYSTEM | JEY Bone Plate |
| 26 Jun 2000 | K000992 | MACROPOREDX DISTRACTOR SYSTEM | MQN External Mandibular Fixator and/or Distractor |
Some of these clearances are listed with FDA today by another company: Medtronic, Inc. (2), ARCH Medical Solutions - Escondido LLC (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.