Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K241164
IB3D PL Spinal System · Medicrea International S.A.S. (Medtronic) · decided 2024-09-06 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| IB3D™ PL Spinal System | B241C17182209 | MEDICREA INTERNATIONAL | MAX | 03613720286462 |
| IB3D™ PL Spinal System | B241C08062209 | MEDICREA INTERNATIONAL | MAX | 03613720286202 |
| IB3D™ PL Spinal System | B241C14062209 | MEDICREA INTERNATIONAL | MAX | 03613720286264 |
| IB3D™ PL Spinal System | B241C13062209 | MEDICREA INTERNATIONAL | MAX | 03613720286257 |
| IB3D™ PL Spinal System | B241C11182209 | MEDICREA INTERNATIONAL | MAX | 03613720286400 |
| IB3D™ PL Spinal System | B241C11122209 | MEDICREA INTERNATIONAL | MAX | 03613720286325 |
| IB3D™ PL Spinal System | B241C10182209 | MEDICREA INTERNATIONAL | MAX | 03613720286394 |
| IB3D™ PL Spinal System | A24000000 | MEDICREA INTERNATIONAL | MAX | 03613720286677 |
| IB3D™ PL Spinal System | B241C09122209 | MEDICREA INTERNATIONAL | MAX | 03613720286301 |
| IB3D™ PL Spinal System | B241C12062209 | MEDICREA INTERNATIONAL | MAX | 03613720286240 |
| IB3D™ PL Spinal System | B241C13122209 | MEDICREA INTERNATIONAL | MAX | 03613720286349 |
| IB3D™ PL Spinal System | B241C16062209 | MEDICREA INTERNATIONAL | MAX | 03613720286288 |
| IB3D™ PL Spinal System | B241C16122209 | MEDICREA INTERNATIONAL | MAX | 03613720286370 |
| IB3D™ PL Spinal System | B241C17062209 | MEDICREA INTERNATIONAL | MAX | 03613720286295 |
| IB3D™ PL Spinal System | B241C10062209 | MEDICREA INTERNATIONAL | MAX | 03613720286226 |
| IB3D™ PL Spinal System | B241C17122209 | MEDICREA INTERNATIONAL | MAX | 03613720286387 |
| IB3D™ PL Spinal System | B241C15062209 | MEDICREA INTERNATIONAL | MAX | 03613720286271 |
| IB3D™ PL Spinal System | B241C10122209 | MEDICREA INTERNATIONAL | MAX | 03613720286318 |
| IB3D™ PL Spinal System | B241C15122209 | MEDICREA INTERNATIONAL | MAX | 03613720286363 |
| IB3D™ PL Spinal System | B241C12122209 | MEDICREA INTERNATIONAL | MAX | 03613720286332 |
| IB3D™ PL Spinal System | B241C11062209 | MEDICREA INTERNATIONAL | MAX | 03613720286233 |
| IB3D™ PL Spinal System | B241C16182209 | MEDICREA INTERNATIONAL | MAX | 03613720286455 |
| IB3D™ PL Spinal System | B241C14122209 | MEDICREA INTERNATIONAL | MAX | 03613720286356 |
| IB3D™ PL Spinal System | B241C12182209 | MEDICREA INTERNATIONAL | MAX | 03613720286417 |
| IB3D™ PL Spinal System | B241C13182209 | MEDICREA INTERNATIONAL | MAX | 03613720286424 |