ENOS Software Guided External Fixation System - 1
2026-04-02
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3018064242 | 3018064242 | DISIOR OY | 1 | N | 2026-01-01 | HTC Helsinki, Building Pinta, Tammasaarenkatu 3 Helsinki Uusimaa FI 00180 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 06429810209023 | Bonelogic - Bonelogic 2 | +358504836433 | anna-maria@disior.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 288164 | 1352500718 | K253764 | ENOS Software Guided External Fixation System | OSN | 2026-02-26 |
| 288164 | 1536661109 | K250023 | SMART PCFD | QIH | 2025-09-29 |
| 288164 | 1599501953 | K240736 | SMART Bun-Yo-Matic X-Ray | QIH | 2024-07-02 |
| 288164 | 1226933703 | K240642 | SMART Bun-Yo-Matic CT | QIH | 2024-06-20 |
| 288164 | 1166505979 | K223757 | Bonelogic | QIH | 2023-12-08 |
| 288164 | 1968846979 | K203290 | Bonelogic | LLZ | 2021-02-05 |
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