The following data is part of a premarket notification filed by Bionx Implants, Ltd. with the FDA for Meniscus Arrow, Models 531110, 531113, 531116.
| Device ID | K993453 |
| 510k Number | K993453 |
| Device Name: | MENISCUS ARROW, MODELS 531110, 531113, 531116 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-13 |
| Decision Date | 1999-11-09 |
| Summary: | summary |