The following data is part of a premarket notification filed by Bionx Implants, Ltd. with the FDA for Impact Suture Anchor. Model 433510.
| Device ID | K030388 |
| 510k Number | K030388 |
| Device Name: | IMPACT SUTURE ANCHOR. MODEL 433510 |
| Classification | Screw, Fixation, Bone |
| Applicant | BIONX IMPLANTS, LTD. HERMIANKATU 6-8 L Tampere, FI Fin-33720 |
| Contact | Tuija Annala |
| Correspondent | Tuija Annala BIONX IMPLANTS, LTD. HERMIANKATU 6-8 L Tampere, FI Fin-33720 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-05 |
| Decision Date | 2003-04-24 |
| Summary: | summary |