The following data is part of a premarket notification filed by Inion Oy with the FDA for Inion Cps Orbital Plates.
| Device ID | K122890 |
| 510k Number | K122890 |
| Device Name: | INION CPS ORBITAL PLATES |
| Classification | Plate, Bone |
| Applicant | INION OY LAAKARINKATU 2 Tampere, FI 33520 |
| Contact | Kati Marttinen |
| Correspondent | Kati Marttinen INION OY LAAKARINKATU 2 Tampere, FI 33520 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-20 |
| Decision Date | 2013-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438408011122 | K122890 | 000 |
| M224PLT10829 | K122890 | 000 |
| M224PLT10819 | K122890 | 000 |
| 06438408000515 | K122890 | 000 |
| 06438408000508 | K122890 | 000 |
| 06438408000492 | K122890 | 000 |
| 06438408000485 | K122890 | 000 |
| 06438408000478 | K122890 | 000 |
| 06438408000461 | K122890 | 000 |
| M224PLT10839 | K122890 | 000 |
| M224PLT10849 | K122890 | 000 |
| M224PLT10859 | K122890 | 000 |
| 06438408011115 | K122890 | 000 |
| 06438408011108 | K122890 | 000 |
| 06438408011092 | K122890 | 000 |
| 06438408011085 | K122890 | 000 |
| 06438408011078 | K122890 | 000 |
| 06438408011061 | K122890 | 000 |
| M224PLT10879 | K122890 | 000 |
| M224PLT10869 | K122890 | 000 |
| 06438408000454 | K122890 | 000 |