The following data is part of a premarket notification filed by Bionx Implants, Inc. with the FDA for Contour Meniscus Arrow, Models 541110, 541113, And 541116.
| Device ID | K012334 |
| 510k Number | K012334 |
| Device Name: | CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116 |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | BIONX IMPLANTS, INC. HERMIANKATU 6-8 L Tampere, FI Fin-33720 |
| Contact | Tuija Annala |
| Correspondent | Tuija Annala BIONX IMPLANTS, INC. 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 | 2001-07-24 |
| Decision Date | 2001-09-19 |
| Summary: | summary |