The following data is part of a premarket notification filed by Bionx Implants, Inc. with the FDA for Biocuff, Models 225718, 225728, 225736, 235718, 235728, 235736.
| Device ID | K001378 |
| 510k Number | K001378 |
| Device Name: | BIOCUFF, MODELS 225718, 225728, 225736, 235718, 235728, 235736 |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| 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 | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-01 |
| Decision Date | 2000-07-28 |