The following data is part of a premarket notification filed by Bionx Implants, Ltd. with the FDA for Duet Suture Anchor.
| Device ID | K020056 |
| 510k Number | K020056 |
| Device Name: | DUET SUTURE ANCHOR |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-08 |
| Decision Date | 2002-06-26 |
| Summary: | summary |