The following data is part of a premarket notification filed by Bionx Implants, Inc. with the FDA for Biosorbfx O/m 2.0/2/4 System.
| Device ID | K011569 |
| 510k Number | K011569 |
| Device Name: | BIOSORBFX O/M 2.0/2/4 SYSTEM |
| Classification | Plate, Bone |
| 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 | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-21 |
| Decision Date | 2002-02-22 |
| Summary: | summary |