The following data is part of a premarket notification filed by Inion Oy with the FDA for Inion Biorestore.
| Device ID | K191764 |
| 510k Number | K191764 |
| Device Name: | Inion BioRestore |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | Inion Oy Lääkärinkatu 2 Tampere, FI 33520 |
| Contact | Tiina Tyni |
| Correspondent | Tiina Tyni Inion Oy Lääkärinkatu 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 | 2019-07-01 |
| Decision Date | 2019-07-31 |
| Summary: | summary |