The following data is part of a premarket notification filed by Inion Ltd. with the FDA for Inion Cps Baby 1.5 Bioabsorbable Fixation System, 40 And 64 Hole Plates, Models Plt-1058 And Plt-1059.
| Device ID | K051341 |
| 510k Number | K051341 |
| Device Name: | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM, 40 AND 64 HOLE PLATES, MODELS PLT-1058 AND PLT-1059 |
| Classification | Plate, Bone |
| Applicant | INION LTD. LAAKARINKATU 2 Tampere, FI 33520 |
| Contact | Hanna Marttila |
| Correspondent | Hanna Marttila INION LTD. LAAKARINKATU 2 Tampere, FI 33520 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-05-23 |
| Decision Date | 2005-05-27 |
| Summary: | summary |