The following data is part of a premarket notification filed by Bionx Implants, Ltd. with the FDA for Smartwedge Acl, Models 430623, 430628, 430723, 430728, 430823, 430828.
| Device ID | K000616 |
| 510k Number | K000616 |
| Device Name: | SMARTWEDGE ACL, MODELS 430623, 430628, 430723, 430728, 430823, 430828 |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | BIONX IMPLANTS, LTD. HERMIANKATU 6-8 L Tampere, FI Fin-33720 |
| Contact | Tuija Annala |
| Correspondent | Tuija Annala BIONX IMPLANTS, LTD. HERMIANKATU 6-8 L Tampere, FI Fin-33720 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-02-24 |
| Decision Date | 2000-03-23 |