The following data is part of a premarket notification filed by Inion Ltd. with the FDA for Inion Otps Biodegradable Mesh Plating System.
| Device ID | K031961 |
| 510k Number | K031961 |
| Device Name: | INION OTPS BIODEGRADABLE MESH PLATING SYSTEM |
| Classification | Plate, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-25 |
| Decision Date | 2004-03-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M224MSH10359 | K031961 | 000 |
| 06438408006241 | K031961 | 000 |
| 06438408006234 | K031961 | 000 |
| 06438408006227 | K031961 | 000 |
| 06438408006210 | K031961 | 000 |
| 06438408006203 | K031961 | 000 |
| 06438408005770 | K031961 | 000 |
| 06438408005763 | K031961 | 000 |
| 06438408005756 | K031961 | 000 |
| 06438408006258 | K031961 | 000 |
| M224FRF12359 | K031961 | 000 |
| M224MSH10349 | K031961 | 000 |
| M224MSH10339 | K031961 | 000 |
| M224MSH10329 | K031961 | 000 |
| M224FRF12459 | K031961 | 000 |
| M224FRF12449 | K031961 | 000 |
| M224FRF12389 | K031961 | 000 |
| M224FRF12379 | K031961 | 000 |
| M224FRF12369 | K031961 | 000 |
| 06438408005749 | K031961 | 000 |