The following data is part of a premarket notification filed by Inion Ltd. with the FDA for Inion Trinion Biodegradable Meniscus Screw.
| Device ID | K031714 |
| 510k Number | K031714 |
| Device Name: | INION TRINION BIODEGRADABLE MENISCUS SCREW |
| 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 | 2003-06-02 |
| Decision Date | 2004-08-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M224SET30029 | K031714 | 000 |
| M224MRD30109 | K031714 | 000 |
| M224INS92159 | K031714 | 000 |
| M224INS921510 | K031714 | 000 |