Spinal Fixation System
CANWELL MEDICAL CO., LTD.
CANWELL MEDICAL CO., LTD.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3006395932 | 3006395932 | CANWELL MEDICAL CO., LTD. | 1 | N | 2026-01-01 | No. 466, South Xianhua Street., High-Tech Industrial Zone, Jinhua Zhejiang CN 321016 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 84187 | 1551567828 | K242973 | CanMINI Hand and Foot System | HRS | 2025-04-24 |
| 84187 | 1011173710 | ||||
| 84187 | 1076036096 | ||||
| 84187 | 1104245477 | ||||
| 84187 | 1119614160 | ||||
| 84187 | 1130086062 | ||||
| 84187 | 1168821065 | ||||
| 84187 | 1188854080 | ||||
| 84187 | 1189066474 | ||||
| 84187 | 1199278587 | ||||
| 84187 | 1242555164 | ||||
| 84187 | 1258585722 | ||||
| 84187 | 1292975749 | ||||
| 84187 | 1383789373 | ||||
| 84187 | 1406323657 | ||||
| 84187 | 1593618365 | ||||
| 84187 | 1662643883 | ||||
| 84187 | 1823321619 | ||||
| 84187 | 1862731069 | ||||
| 84187 | 1863166580 | ||||
| 84187 | 1917828285 | ||||
| 84187 | 1965537300 | ||||
| 84187 | 1971329509 | ||||
| 84187 | 1996175042 | ||||
| 84187 | 1999211250 | ||||
| 84187 | 2016963311 | ||||
| 84187 | 2066859374 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| HRS | 1 | 2025-04-24 |