The following data is part of a premarket notification filed by Bionx Implants, Inc. with the FDA for Plla Pin.
| Device ID | K010983 |
| 510k Number | K010983 |
| Device Name: | PLLA PIN |
| Classification | Pin, Fixation, Smooth |
| 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 | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-02 |
| Decision Date | 2001-06-13 |