Bionx Implants, Inc.
Medical device manufacturer in Tampere, FI.
30510(k) clearances
0PMA approvals
0recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K030388 | Impact Suture Anchor. Model 433510HWC · Traditional | 04/24/2003SE |
| K023022 | Nugen FX ScrewHWC · Special | 10/04/2002SE |
| K020056 | Duet Suture AnchorHWC · Traditional | 06/26/2002SE |
| K011569 | Biosorbfx O/M 2.0/2/4 SystemJEY · Traditional | 02/22/2002SE |
| K013546 | Modification to: 1.5 Bone Fixation Kit, Models BXS6114, BXS6214HWC · Special | 11/21/2001SE |
| K013057 | Biocuff,C, Models 236018, 236028, 236036MAI · Special | 10/12/2001SE |
| K012334 | Contour Meniscus Arrow, Models 541110, 541113, and 541116MAI · Special | 09/19/2001SE |
| K012001 | SmartscrewHWC · Special | 07/18/2001SE |
| K012000 | 1.5MM Bone Fixation KitHWC · Special | 07/18/2001SE |
| K010983 | Plla PinHTY · Special | 06/13/2001SE |
| K010554 | Meniscus Arrow Sheath #CN1000A; Smartscrew Acl Sheath #SSA2000AHWC · Traditional | 05/25/2001SE |
| K003077 | Smartscrew Model 222006...227510HWC · Traditional | 04/26/2001SE |
| K010687 | Biosorbfx and Biosorbpdx MeshJEY · Special | 03/14/2001SE |
| K003659 | Plga Pin, Model 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260HTY · Traditional | 02/20/2001SE |
| K003757 | Thermofx MeshJEY · Traditional | 02/07/2001SE |
| K003970 | Contour Labral Nail, Model 533520AMAI · Special | 01/12/2001SE |
| K003756 | Biosorbfx Tack and Biosorbpdx Tack Bioabsorbable Fixation Fastener, Used with PlatesJEY · Special | 01/03/2001SE |
| K001378 | Biocuff, Models 225718, 225728, 225736, 235718, 235728, 235736MAI · Traditional | 07/28/2000SE |
| K000836 | Biosorbpdx Bioabsorbable Fixation SystemJEY · Traditional | 06/08/2000SE |
| K000616 | Smartwedge Acl, Models 430623, 430628, 430723, 430728, 430823, 430828MAI · Special | 03/23/2000SE |
| K993074 | Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525MAI · Traditional | 12/10/1999SE |
| K993073 | Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025…MAI · Traditional | 12/06/1999SE |
| K993453 | Meniscus Arrow, Models 531110, 531113, 531116MAI · Special | 11/09/1999SE |
| K992947 | Cannulated Smartscrew Models 224540C, 224570CHWC · Special | 09/21/1999SE |
| K992567 | Anatomical Bankart Tack, Model 523520AMAI · Special | 08/27/1999SE |
| K982721 | Biosorbfx 2.0/2.4 Orthognathic and Mandibular Fixation SystemJEY · Traditional | 02/17/1999SE |
| K982139 | Biosorbfx 1.5/2.0 Bioabsorbable Fixation SystemJEY · Traditional | 09/15/1998SE |
| K972783 | Biofix Biodegradable Threaded Suture AnchorMAI · Traditional | 04/14/1998SE |
| K972919 | Biofix Bioabsorbable Self-Reinforced Poly-L-Lactide Threaded Browlift ScrewHWC · Traditional | 03/27/1998SE |
| K974876 | Bionx Distal Radius ScrewMAI · Traditional | 03/20/1998SE |