The following data is part of a premarket notification filed by Inion Oy with the FDA for Inion Freedompin.
| Device ID | K133932 |
| 510k Number | K133932 |
| Device Name: | INION FREEDOMPIN |
| Classification | Pin, Fixation, Smooth |
| Applicant | INION OY LAAKARINKATU 2 Tampere, FI 33520 |
| Contact | Kati Marttinen |
| Correspondent | Kati Marttinen INION OY 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 | 2013-12-23 |
| Decision Date | 2014-04-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06438408012334 | K133932 | 000 |
| 06438408004230 | K133932 | 000 |
| 06438408004247 | K133932 | 000 |
| 06438408004254 | K133932 | 000 |
| 06438408004261 | K133932 | 000 |
| 06438408004278 | K133932 | 000 |
| 06438408004285 | K133932 | 000 |
| 06438408004292 | K133932 | 000 |
| 06438408004308 | K133932 | 000 |
| 06438408004315 | K133932 | 000 |
| 06438408004322 | K133932 | 000 |
| 06438408004339 | K133932 | 000 |
| 06438408004346 | K133932 | 000 |
| 06438408004223 | K133932 | 000 |
| 06438408004216 | K133932 | 000 |
| 06438408004209 | K133932 | 000 |
| 06438408012341 | K133932 | 000 |
| 06438408012358 | K133932 | 000 |
| 06438408012365 | K133932 | 000 |
| 06438408012372 | K133932 | 000 |
| 06438408012389 | K133932 | 000 |
| 06438408004131 | K133932 | 000 |
| 06438408004148 | K133932 | 000 |
| 06438408004155 | K133932 | 000 |
| 06438408004162 | K133932 | 000 |
| 06438408004179 | K133932 | 000 |
| 06438408004186 | K133932 | 000 |
| 06438408004193 | K133932 | 000 |
| 06438408004353 | K133932 | 000 |
| 06438408004360 | K133932 | 000 |
| M224OPA27609 | K133932 | 000 |
| M224OPA27709 | K133932 | 000 |
| M224OPA32309 | K133932 | 000 |
| M224OPA32409 | K133932 | 000 |
| M224OPA32509 | K133932 | 000 |
| M224OPA32609 | K133932 | 000 |
| M224OPA32709 | K133932 | 000 |
| M224OPK15K19 | K133932 | 000 |
| M224OPK15K29 | K133932 | 000 |
| M224OPK15K39 | K133932 | 000 |
| M224OPK20K19 | K133932 | 000 |
| M224OPK20K29 | K133932 | 000 |
| M224OPA27509 | K133932 | 000 |
| M224OPA27409 | K133932 | 000 |
| M224OPA27309 | K133932 | 000 |
| 06438408004377 | K133932 | 000 |
| 06438408004384 | K133932 | 000 |
| M224OPA15309 | K133932 | 000 |
| M224OPA15409 | K133932 | 000 |
| M224OPA15509 | K133932 | 000 |
| M224OPA15609 | K133932 | 000 |
| M224OPA15709 | K133932 | 000 |
| M224OPA20309 | K133932 | 000 |
| M224OPA20409 | K133932 | 000 |
| M224OPA20509 | K133932 | 000 |
| M224OPA20609 | K133932 | 000 |
| M224OPA20709 | K133932 | 000 |
| M224OPK20K39 | K133932 | 000 |