The following data is part of a premarket notification filed by Bionx Implants, Inc. with the FDA for Plga Pin, Model 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260.
| Device ID | K003659 |
| 510k Number | K003659 |
| Device Name: | PLGA PIN, MODEL 171120,171140,171520,171540,171560,172020,172040,172060,173240,173260 |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-28 |
| Decision Date | 2001-02-20 |