Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K231527
TriALTIS Navigation Enabled Instruments · Medos International Sàrl · decided 2023-09-29 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| TRIALTIS | 5161-00-5089 | Medos International Sàrl | OLO | 10705034589275 |
| TRIALTIS Spine System | 5161005106 | DEPUY SPINE, LLC | OLO | 10705034592558 |
| TRIALTIS | 5161-00-2090 | Medos International Sàrl | OLO | 10705034589442 |
| TRIALTIS | 5161-00-1080 | Medos International Sàrl | OLO | 10705034589589 |
| TRIALTIS | 5161-00-2070 | Medos International Sàrl | OLO | 10705034589404 |
| TRIALTIS | 5161-00-1090 | Medos International Sàrl | OLO | 10705034589602 |
| TRIALTIS | 5161-00-1105 | Medos International Sàrl | OLO | 10705034589473 |
| TRIALTIS | 5161-00-1060 | Medos International Sàrl | OLO | 10705034589541 |
| TRIALTIS | 5161-00-5066 | Medos International Sàrl | OLO | 10705034589244 |
| TRIALTIS | 5161-00-1040 | Medos International Sàrl | OLO | 10705034589503 |
| TRIALTIS | 5161-00-1110 | Medos International Sàrl | OLO | 10705034589480 |
| TRIALTIS | 5161-00-2100 | Medos International Sàrl | OLO | 10705034589299 |
| TRIALTIS | 5161-00-2045 | Medos International Sàrl | OLO | 10705034589350 |
| TRIALTIS Spine System | 5161005113 | DEPUY SPINE, LLC | OLO | 10705034589763 |
| TRIALTIS | 5161-00-1045 | Medos International Sàrl | OLO | 10705034589510 |
| TRIALTIS | 5161-00-5069 | Medos International Sàrl | OLO | 10705034589282 |
| TRIALTIS | 5161-00-1035 | Medos International Sàrl | OLO | 10705034598949 |
| TRIALTIS | 5161-00-2080 | Medos International Sàrl | OLO | 10705034589428 |
| TRIALTIS | 5161-00-2040 | Medos International Sàrl | OLO | 10705034589343 |
| TRIALTIS | 5161-00-5062 | Medos International Sàrl | OLO | 10705034592312 |
| TRIALTIS | 5161-00-5064 | Medos International Sàrl | OLO | 10705034592329 |
| TRIALTIS | 5161-00-2035 | Medos International Sàrl | OLO | 10705034589336 |
| TRIALTIS | 5161-00-2105 | Medos International Sàrl | OLO | 10705034589305 |
| TRIALTIS | 5161-00-1065 | Medos International Sàrl | OLO | 10705034589558 |
| TRIALTIS | 5161-00-2110 | Medos International Sàrl | OLO | 10705034589312 |