The following data is part of a premarket notification filed by Bionx Implants, Ltd. with the FDA for Cannulated Smartscrew Models 224540c, 224570c.
| Device ID | K992947 |
| 510k Number | K992947 |
| Device Name: | CANNULATED SMARTSCREW MODELS 224540C, 224570C |
| 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 | 1999-09-01 |
| Decision Date | 1999-09-21 |
| Summary: | summary |