The following data is part of a premarket notification filed by Inion Oy with the FDA for Inion Biorestore.
| Device ID | K070784 |
| 510k Number | K070784 |
| Device Name: | INION BIORESTORE |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | INION OY LAAKARINKATU 2 Tampere, FI 33520 |
| Contact | Kati Martinen |
| Correspondent | Kati Martinen INION OY LAAKARINKATU 2 Tampere, FI 33520 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-21 |
| Decision Date | 2007-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M224BRS21209 | K070784 | 000 |
| 06438408009051 | K070784 | 000 |
| 06438408009594 | K070784 | 000 |
| 06438408009631 | K070784 | 000 |
| 06438408009648 | K070784 | 000 |
| 06438408009693 | K070784 | 000 |
| 06438408009655 | K070784 | 000 |
| 06438408009662 | K070784 | 000 |
| 06438408009679 | K070784 | 000 |
| 06438408009686 | K070784 | 000 |
| M224BRS14009 | K070784 | 000 |
| M224BRS14019 | K070784 | 000 |
| M224BRS16009 | K070784 | 000 |
| M224BRS16019 | K070784 | 000 |
| M224BRS16109 | K070784 | 000 |
| 06438408007941 | K070784 | 000 |