The following data is part of a premarket notification filed by Inion Ltd. with the FDA for Inion Cps/otps Freedomplate.
| Device ID | K063410 |
| 510k Number | K063410 |
| Device Name: | INION CPS/OTPS FREEDOMPLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | INION LTD. LAAKARINKATU 2 Tampere, FI 33520 |
| Contact | Kati Marttinen |
| Correspondent | Kati Marttinen INION LTD. LAAKARINKATU 2 Tampere, FI 33520 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-13 |
| Decision Date | 2007-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438408011337 | K063410 | 000 |
| 06438408005695 | K063410 | 000 |
| 06438408005701 | K063410 | 000 |
| 06438408005718 | K063410 | 000 |
| M224FRF10639 | K063410 | 000 |
| M224FRF10649 | K063410 | 000 |
| M224FRF10659 | K063410 | 000 |
| M224FRF10669 | K063410 | 000 |
| M224FRF10639I0 | K063410 | 000 |
| 06438408000690 | K063410 | 000 |
| 06438408000706 | K063410 | 000 |
| 06438408000713 | K063410 | 000 |
| 06438408000720 | K063410 | 000 |
| 06438408011306 | K063410 | 000 |
| 06438408011313 | K063410 | 000 |
| 06438408011320 | K063410 | 000 |
| 06438408005688 | K063410 | 000 |