The following data is part of a premarket notification filed by Bionx Implants, Inc. with the FDA for Biosorbpdx Bioabsorbable Fixation System.
| Device ID | K000836 |
| 510k Number | K000836 |
| Device Name: | BIOSORBPDX BIOABSORBABLE FIXATION 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 | 2000-03-14 |
| Decision Date | 2000-06-08 |