The following data is part of a premarket notification filed by Inion Ltd. with the FDA for Inion Cps Bsso Screw.
| Device ID | K020266 |
| 510k Number | K020266 |
| Device Name: | INION CPS BSSO SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | INION LTD. LAAKARINKATU 2 Tampere, FI Fin-33520 |
| Contact | Hanna Marttila |
| Correspondent | Hanna Marttila INION LTD. LAAKARINKATU 2 Tampere, FI Fin-33520 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-01-25 |
| Decision Date | 2002-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438408000942 | K020266 | 000 |
| 06438408001352 | K020266 | 000 |
| 06438408001369 | K020266 | 000 |
| 06438408001376 | K020266 | 000 |
| M224SCR12129 | K020266 | 000 |
| M224SCR12139 | K020266 | 000 |
| M224SCR12149 | K020266 | 000 |
| M224SCR12159 | K020266 | 000 |
| M224SCR12169 | K020266 | 000 |
| M224SCR12269 | K020266 | 000 |
| 06438408001345 | K020266 | 000 |
| 06438408001338 | K020266 | 000 |
| 06438408000959 | K020266 | 000 |
| 06438408000966 | K020266 | 000 |
| 06438408000973 | K020266 | 000 |
| 06438408000980 | K020266 | 000 |
| 06438408000997 | K020266 | 000 |
| 06438408001000 | K020266 | 000 |
| 06438408001017 | K020266 | 000 |
| 06438408001024 | K020266 | 000 |
| 06438408001031 | K020266 | 000 |
| M224SCR12279 | K020266 | 000 |
| M224SCR12289 | K020266 | 000 |
| M224SCR12299 | K020266 | 000 |
| 06438408011603 | K020266 | 000 |
| 06438408011610 | K020266 | 000 |
| 06438408011627 | K020266 | 000 |
| 06438408011634 | K020266 | 000 |
| 06438408011641 | K020266 | 000 |
| 06438408011948 | K020266 | 000 |
| 06438408011955 | K020266 | 000 |
| 06438408011962 | K020266 | 000 |
| 06438408011979 | K020266 | 000 |
| 06438408011597 | K020266 | 000 |
| 06438408011580 | K020266 | 000 |
| M224SCR12309 | K020266 | 000 |
| M224SCR12979 | K020266 | 000 |
| M224SCR12989 | K020266 | 000 |
| M224SCR12999 | K020266 | 000 |
| M224SCR13009 | K020266 | 000 |
| M224SCR13019 | K020266 | 000 |
| 06438408011559 | K020266 | 000 |
| 06438408011566 | K020266 | 000 |
| 06438408011573 | K020266 | 000 |
| 06438408011986 | K020266 | 000 |