The following data is part of a premarket notification filed by Inion Oy with the FDA for Inion Anchron Biodegradable Anchor System, Model Anc-6000.
| Device ID | K051362 |
| 510k Number | K051362 |
| Device Name: | INION ANCHRON BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6000 |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | INION OY LAAKARINKATU 2 Tampere, FI Fin-33520 |
| Contact | Hanna Martila |
| Correspondent | Hanna Martila INION OY LAAKARINKATU 2 Tampere, FI Fin-33520 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-25 |
| Decision Date | 2005-08-04 |
| Summary: | summary |