The following data is part of a premarket notification filed by Inion Oy with the FDA for Inion Spinal Graft Containment System.
| Device ID | K151360 |
| 510k Number | K151360 |
| Device Name: | Inion Spinal Graft Containment System |
| Classification | Resorbable Spinal Intervertebral Body Fixation Orthosis - Plate |
| Applicant | Inion Oy Lääkärinkatu 2 Tampere, FI 33520 |
| Contact | Kati Marttinen |
| Correspondent | Kati Marttinen Inion Oy Lääkärinkatu 2 Tampere, FI 33520 |
| Product Code | OJB |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Se - With Limitations (SESU) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-20 |
| Decision Date | 2015-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M224C609 | K151360 | 000 |
| M224SPN54229 | K151360 | 000 |
| M224SPN54239 | K151360 | 000 |
| M224SPN54249 | K151360 | 000 |
| 06438408007057 | K151360 | 000 |
| 06438408007064 | K151360 | 000 |
| 06438408007071 | K151360 | 000 |
| 06438408007088 | K151360 | 000 |
| 06438408007613 | K151360 | 000 |
| M224C6010 | K151360 | 000 |
| M224SPN54219 | K151360 | 000 |