The following data is part of a premarket notification filed by Bionx Implants, Ltd. with the FDA for 1.5mm Bone Fixation Kit.
| Device ID | K012000 |
| 510k Number | K012000 |
| Device Name: | 1.5MM BONE FIXATION KIT |
| Classification | Screw, Fixation, Bone |
| Applicant | BIONX IMPLANTS, LTD. P.O. BOX 3 HERMINKATU 6-8L Tampere, FI Sp-33721 |
| Contact | Tuija Annala |
| Correspondent | Tuija Annala BIONX IMPLANTS, LTD. P.O. BOX 3 HERMINKATU 6-8L Tampere, FI Sp-33721 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-27 |
| Decision Date | 2001-07-18 |
| Summary: | summary |