The following data is part of a premarket notification filed by Inion Ltd. with the FDA for Inion Otps Biodegradable Fixaton System.
| Device ID | K030900 |
| 510k Number | K030900 |
| Device Name: | INION OTPS BIODEGRADABLE FIXATON SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | INION LTD. LAAKARINKATU 2 Tampere, FI 33520 |
| Contact | Hanna Marttila |
| Correspondent | Hanna Marttila INION LTD. LAAKARINKATU 2 Tampere, FI 33520 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-24 |
| Decision Date | 2003-06-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M224INS90849 | K030900 | 000 |
| 06438408006463 | K030900 | 000 |
| 06438408006470 | K030900 | 000 |
| 06438408006487 | K030900 | 000 |
| 06438408006494 | K030900 | 000 |
| 06438408006500 | K030900 | 000 |
| M224FRF12729 | K030900 | 000 |
| M224FRF12739 | K030900 | 000 |
| M224FRF12749 | K030900 | 000 |
| M224FRF12759 | K030900 | 000 |
| M224FRF12779 | K030900 | 000 |
| M224FRF12789 | K030900 | 000 |
| M224INS908310 | K030900 | 000 |
| M224INS90839 | K030900 | 000 |
| M224INS908410 | K030900 | 000 |
| 06438408006456 | K030900 | 000 |