Not currently registered with FDA under this name
Bionx Implants, Inc.
Tampere, Finland. Named as applicant on 7 dental 510(k) clearances between 1998 and 2002. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 71998–2002
- Markets registered in
- 310 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 3 markets
Where regulators' registries name Bionx Implants, 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 | Bionx Implants, Inc. | 7 clearances | 1998–2002 | Below |
| Taiwan | TFDA | Manufacturer | BIONX IMPLANTS LTD. | 6 | 2002–2003 | Pure Global AI |
| South Korea | MFDS | Manufacturer | BIONX IMPLANTS LTDBIONX Implants Ltd. | 4 | 1999–2001 | 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 Bionx Implants, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 22 Feb 2002 | K011569 | BIOSORBFX O/M 2.0/2/4 SYSTEM | JEY Bone Plate |
| 14 Mar 2001 | K010687 | BIOSORBFX AND BIOSORBPDX MESH | JEY Bone Plate |
| 7 Feb 2001 | K003757 | THERMOFX MESH | JEY Bone Plate |
| 3 Jan 2001 | K003756 | BIOSORBFX TACK AND BIOSORBPDX TACK BIOABSORBABLE FIXATION FASTENER, USED WITH PLATES | JEY Bone Plate |
| 8 Jun 2000 | K000836 | BIOSORBPDX BIOABSORBABLE FIXATION SYSTEM | JEY Bone Plate |
| 17 Feb 1999 | K982721 | BIOSORBFX 2.0/2.4 ORTHOGNATHIC AND MANDIBULAR FIXATION SYSTEM | JEY Bone Plate |
| 15 Sep 1998 | K982139 | BIOSORBFX 1.5/2.0 BIOABSORBABLE FIXATION SYSTEM | JEY Bone Plate |
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.