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.
| Device ID | K010351 |
| 510k Number | K010351 |
| Device Name: | INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | INION LTD. 3 SORINKATU Tampere, FI 33100 |
| Contact | Hanna Marttila |
| Correspondent | Hanna Marttila INION LTD. 3 SORINKATU Tampere, FI 33100 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-06 |
| Decision Date | 2001-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438408000027 | K010351 | 000 |
| M224PLT10289 | K010351 | 000 |
| M224PLT10299 | K010351 | 000 |
| M224SCR12109 | K010351 | 000 |
| M224SCR12119 | K010351 | 000 |
| M224SCR12209 | K010351 | 000 |
| M224SCR12219 | K010351 | 000 |
| M224INS902710 | K010351 | 000 |
| M224INS90279 | K010351 | 000 |
| M224INS903010 | K010351 | 000 |
| M224PLT10049 | K010351 | 000 |
| M224PLT10039 | K010351 | 000 |
| 06438408000034 | K010351 | 000 |
| 06438408000041 | K010351 | 000 |
| 06438408000058 | K010351 | 000 |
| 06438408000065 | K010351 | 000 |
| 06438408000133 | K010351 | 000 |
| 06438408000140 | K010351 | 000 |
| M224PLT10009 | K010351 | 000 |
| M224PLT10019 | K010351 | 000 |
| M224PLT10029 | K010351 | 000 |
| M224INS90309 | K010351 | 000 |
| M224INS926110 | K010351 | 000 |
| M224INS92619 | K010351 | 000 |
| 06438408010828 | K010351 | 000 |
| 06438408010835 | K010351 | 000 |
| 06438408010842 | K010351 | 000 |
| 06438408010859 | K010351 | 000 |
| 06438408010880 | K010351 | 000 |
| 06438408010897 | K010351 | 000 |
| 06438408010927 | K010351 | 000 |
| 06438408010934 | K010351 | 000 |
| 06438408000096 | K010351 | 000 |
| 06438408010811 | K010351 | 000 |
| M224INS92729 | K010351 | 000 |
| M224INS926210 | K010351 | 000 |
| M224INS92629 | K010351 | 000 |
| M224INS926310 | K010351 | 000 |
| M224INS92639 | K010351 | 000 |
| M224INS926410 | K010351 | 000 |
| M224INS92649 | K010351 | 000 |
| M224INS927110 | K010351 | 000 |
| M224INS92719 | K010351 | 000 |
| M224INS927210 | K010351 | 000 |
| 06438408000102 | K010351 | 000 |