The following data is part of a premarket notification filed by Inion Oy with the FDA for Inion Biorestore Biodegradable Bone Graft Substitute.
| Device ID | K090177 |
| 510k Number | K090177 |
| Device Name: | INION BIORESTORE BIODEGRADABLE BONE GRAFT SUBSTITUTE |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | INION OY LAAKARINKATU 2 Tampere, FI 33520 |
| Contact | Kati Marttinen |
| Correspondent | Kati Marttinen INION OY LAAKARINKATU 2 Tampere, FI 33520 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-23 |
| Decision Date | 2009-02-20 |
| Summary: | summary |