Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K231504
TITANEX MICROBEAM Screw System, TITANEX ARTEMIS Screw System · Vilex, LLC · decided 2023-09-11 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| TITANEX | AZ-K190-11C | VILEX LLC | HXI | 00841731142870 |
| TITANEX | AC40-70T-16 | VILEX LLC | HWC | 00841731141347 |
| TITANEX | AZ-100-TRY | VILEX LLC | FSM | 00841731147653 |
| TITANEX | AC40-26T-16C | VILEX LLC | HWC | 00841731140845 |
| TITANEX | AC40-28T-16 | VILEX LLC | HWC | 00841731141132 |
| TITANEX | AC30-34T-11C | VILEX LLC | HWC | 00841731140081 |
| TITANEX | AC40-68T-16 | VILEX LLC | HWC | 00841731141330 |
| TITANEX | AC30-46T-11C | VILEX LLC | HWC | 00841731140142 |
| TITANEX | TH20-22T-09 | VILEX LLC | HWC | 00841731137579 |
| TITANEX | AC30-26T-11 | VILEX LLC | HWC | 00841731140241 |
| TITANEX | AC30-42T-11C | VILEX LLC | HWC | 00841731140128 |
| TITANEX | TH20-36T-09 | VILEX LLC | HWC | 00841731137647 |
| TITANEX | AC40-40T-16C | VILEX LLC | HWC | 00841731140913 |
| TITANEX | AC40-66T-16 | VILEX LLC | HWC | 00841731141323 |
| TITANEX | TH20-34T-09 | VILEX LLC | HWC | 00841731137630 |
| TITANEX | AC40-20T-16C | VILEX LLC | HWC | 00841731140814 |
| TITANEX | TH25-42T-11 | VILEX LLC | HWC | 00841731137852 |
| TITANEX | AC40-64T-16 | VILEX LLC | HWC | 00841731141316 |
| TITANEX | AC30-22T-11 | VILEX LLC | HWC | 00841731140227 |
| TITANEX | AC40-52T-16C | VILEX LLC | HWC | 00841731140975 |
| TITANEX | AC30-40T-11C | VILEX LLC | HWC | 00841731140111 |
| TITANEX | TH20-46T-09 | VILEX LLC | HWC | 00841731137692 |
| TITANEX | AZ-P102-22 | VILEX LLC | LXH | 00841731148957 |
| TITANEX | AC40-20T-16 | VILEX LLC | HWC | 00841731141095 |
| TITANEX | TH-DRILL-20 | VILEX LLC | HTW | 00841731137913 |