The following data is part of a premarket notification filed by Inion Oy with the FDA for Inion Anchron Plus Biodegradable Anchor System, Model Anc-6001.
| Device ID | K062782 |
| 510k Number | K062782 |
| Device Name: | INION ANCHRON PLUS BIODEGRADABLE ANCHOR SYSTEM, MODEL ANC-6001 |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | INION OY LAAKARINKATU 2 Tampere, FI 33520 |
| Contact | Kati Marttinen |
| Correspondent | Kati Marttinen INION OY LAAKARINKATU 2 Tampere, FI 33520 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-18 |
| Decision Date | 2006-11-09 |
| Summary: | summary |