The following data is part of a premarket notification filed by Bionx Implants, Ltd. with the FDA for Smart Nail Models 521516, 521520,521525, 531516, 531520. 531525.
| Device ID | K993074 |
| 510k Number | K993074 |
| Device Name: | SMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525 |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| 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 | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-14 |
| Decision Date | 1999-12-10 |
| Summary: | summary |