The following data is part of a premarket notification filed by Bionx Implants, Inc. with the FDA for Modification To: 1.5 Bone Fixation Kit, Models Bxs6114, Bxs6214.
| Device ID | K013546 |
| 510k Number | K013546 |
| Device Name: | MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214 |
| Classification | Screw, Fixation, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-24 |
| Decision Date | 2001-11-21 |
| Summary: | summary |