The following data is part of a premarket notification filed by Inion Ltd. with the FDA for Modification To: Inion Otps Biodegradable Pin.
| Device ID | K050275 |
| 510k Number | K050275 |
| Device Name: | MODIFICATION TO: 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-07 |
| Decision Date | 2005-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M224PIN50029 | K050275 | 000 |
| 06438408006081 | K050275 | 000 |
| 06438408006074 | K050275 | 000 |
| 06438408006067 | K050275 | 000 |
| 06438408006050 | K050275 | 000 |
| 06438408006043 | K050275 | 000 |
| 06438408006029 | K050275 | 000 |
| 06438408006012 | K050275 | 000 |
| 06438408006005 | K050275 | 000 |
| 06438408005992 | K050275 | 000 |
| 06438408006036 | K050275 | 000 |
| 06438408006098 | K050275 | 000 |
| 06438408006104 | K050275 | 000 |
| M224PIN15209 | K050275 | 000 |
| M224PIN50019 | K050275 | 000 |
| M224PIN20509 | K050275 | 000 |
| M224PIN20409 | K050275 | 000 |
| M224PIN20359 | K050275 | 000 |
| M224PIN20309 | K050275 | 000 |
| M224PIN20259 | K050275 | 000 |
| M224PIN20209 | K050275 | 000 |
| M224PIN15509 | K050275 | 000 |
| M224PIN15409 | K050275 | 000 |
| M224PIN15309 | K050275 | 000 |
| 06438408012419 | K050275 | 000 |