The following data is part of a premarket notification filed by Inion Ltd. with the FDA for Inion Otps Biodegradable Mini Plating System.
| Device ID | K023887 |
| 510k Number | K023887 |
| Device Name: | INION OTPS BIODEGRADABLE MINI PLATING 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 | 2002-11-21 |
| Decision Date | 2003-05-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438408005831 | K023887 | 000 |
| 06438408006166 | K023887 | 000 |
| 06438408006173 | K023887 | 000 |
| 06438408006517 | K023887 | 000 |
| 06438408006524 | K023887 | 000 |
| 06438408006531 | K023887 | 000 |
| 06438408006548 | K023887 | 000 |
| 06438408006555 | K023887 | 000 |
| 06438408006562 | K023887 | 000 |
| 06438408010323 | K023887 | 000 |
| M224FRF12249 | K023887 | 000 |
| 06438408005961 | K023887 | 000 |
| 06438408005954 | K023887 | 000 |
| 06438408005947 | K023887 | 000 |
| 06438408005848 | K023887 | 000 |
| 06438408005855 | K023887 | 000 |
| 06438408005862 | K023887 | 000 |
| 06438408005879 | K023887 | 000 |
| 06438408005886 | K023887 | 000 |
| 06438408005893 | K023887 | 000 |
| 06438408005909 | K023887 | 000 |
| 06438408005916 | K023887 | 000 |
| 06438408005923 | K023887 | 000 |
| 06438408005930 | K023887 | 000 |
| M224FRF12259 | K023887 | 000 |
| M224FRF12849 | K023887 | 000 |
| M224FRF10239 | K023887 | 000 |
| M224FRF10249 | K023887 | 000 |
| M224FRF10259 | K023887 | 000 |
| M224FRF10269 | K023887 | 000 |
| M224FRF10279 | K023887 | 000 |
| M224FRF10369 | K023887 | 000 |
| M224FRF10379 | K023887 | 000 |
| M224FRF10389 | K023887 | 000 |
| M224FRF10399 | K023887 | 000 |
| M224FRF10409 | K023887 | 000 |
| M224FRF10229 | K023887 | 000 |
| M224FRF10169 | K023887 | 000 |
| M224FRF10149 | K023887 | 000 |
| M224FRF12859 | K023887 | 000 |
| M224FRF12869 | K023887 | 000 |
| M224FRF12879 | K023887 | 000 |
| M224FRF12889 | K023887 | 000 |
| M224FRF12899 | K023887 | 000 |
| M224INS909810 | K023887 | 000 |
| M224INS90989 | K023887 | 000 |
| M224INS910510 | K023887 | 000 |
| M224INS91059 | K023887 | 000 |
| M224FRF10139 | K023887 | 000 |
| M224FRF10419 | K023887 | 000 |