The following data is part of a premarket notification filed by Bionx Implants, Ltd. with the FDA for Smart Screw Acl Models 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030.
| Device ID | K993073 |
| 510k Number | K993073 |
| Device Name: | SMART SCREW ACL MODELS 237020, 237025, 237030, 238020, 238025, 238030, 239020, 239025, 239030 |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | BIONX IMPLANTS, LTD. P.O. BOX 3 HERMINKATU 6-8L Tampere, FI Sp-33721 |
| Contact | Tuija Annala |
| Correspondent | Tuija Annala BIONX IMPLANTS, LTD. P.O. BOX 3 HERMINKATU 6-8L Tampere, FI Sp-33721 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-14 |
| Decision Date | 1999-12-06 |
| Summary: | summary |