The following data is part of a premarket notification filed by Inion Ltd. with the FDA for Inion Otps Biodegradable Pin.
| Device ID | K031712 |
| 510k Number | K031712 |
| Device Name: | INION OTPS BIODEGRADABLE PIN |
| Classification | Pin, Fixation, Smooth |
| Applicant | INION LTD. LAAKARINKATU 2 Tampere, FI 33520 |
| Contact | Hanna Marttila |
| Correspondent | Hanna Marttila INION LTD. LAAKARINKATU 2 Tampere, FI 33520 |
| Product Code | HTY |
| 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 | 2003-08-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M224PCK70029 | K031712 | 000 |
| M224PCK70019 | K031712 | 000 |
| 06438408005985 | K031712 | 000 |
| 06438408005978 | K031712 | 000 |
| 06438408012402 | K031712 | 000 |