Recognized a 510(k)/PMA number — showing its clearance record and devices.
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| VBR Omni™ vertebral body replacement | CS 2250-19-194 | Ulrich GmbH & Co. KG | MQP | 04052536178995 |
| VBR Omni™ vertebral body replacement | CS 2250-22-468 | Ulrich GmbH & Co. KG | MQP | 04052536162338 |
| Small VBR (ADD) | CS 2250-12-246 | Ulrich GmbH & Co. KG | MQP PLR | 04052536212804 |
| VBR Omni™ vertebral body replacement | CS 2250-26-4616 | Ulrich GmbH & Co. KG | MQP | 04052536162406 |
| ADD™ anterior distraction device | CS 2250-14-396 | Ulrich GmbH & Co. KG | MQP PLR | 04052536009251 |
| VBR Omni™ vertebral body replacement | CS 2250-26-7216 | Ulrich GmbH & Co. KG | MQP | 04052536179183 |
| VBR Omni™ vertebral body replacement | CS 2250-19-46 | Ulrich GmbH & Co. KG | MQP | 04052536162284 |
| VBR Omni™ vertebral body replacement | CS 2250-19-32 | Ulrich GmbH & Co. KG | MQP | 04052536162277 |
| VBR Omni™ vertebral body replacement | CS 2250-19-24 | Ulrich GmbH & Co. KG | MQP | 04052536162260 |
| VBR Omni™ vertebral body replacement | CS 2250-30-4616 | Ulrich GmbH & Co. KG | MQP | 04052536179237 |
| ADD™ anterior distraction device | CS 2250-14-166 | Ulrich GmbH & Co. KG | MQP PLR | 04052536009237 |
| ADD™ anterior distraction device | CS 2250-16-39 | Ulrich GmbH & Co. KG | MQP PLR | 04052536000029 |
| VBR Omni™ vertebral body replacement | CS 2250-26-464 | Ulrich GmbH & Co. KG | MQP | 04052536179176 |
| Small VBR (ADD) | CS 2250-12-166 | Ulrich GmbH & Co. KG | MQP PLR | 04052536212781 |
| VBR Omni™ vertebral body replacement | CS 2250-19-15 | Ulrich GmbH & Co. KG | MQP | 04052536162246 |
| VBR Omni™ vertebral body replacement | CS 2250-30-324 | Ulrich GmbH & Co. KG | MQP | 04052536179213 |
| ADD™ anterior distraction device | CS 2250-12-24 | Ulrich GmbH & Co. KG | MQP PLR | 04052536004294 |
| VBR Omni™ vertebral body replacement | CS 2250-22-194 | Ulrich GmbH & Co. KG | MQP | 04052536179053 |
| ADD™ anterior distraction device | CS 2250-16-246 | Ulrich GmbH & Co. KG | MQP PLR | 04052536009275 |
| Small VBR (ADD) | CS 2250-14-166 | Ulrich GmbH & Co. KG | MQP PLR | 04052536212866 |
| VBR Omni™ vertebral body replacement | CS 2250-30-4612 | Ulrich GmbH & Co. KG | MQP | 04052536179220 |
| ADD™ anterior distraction device | CS 2250-12-396 | Ulrich GmbH & Co. KG | MQP PLR | 04052536009220 |
| ADDplus | CS 2259 | Ulrich GmbH & Co. KG | MQP PLR | 04052536213023 |
| VBR Omni™ vertebral body replacement | CS 2250-19-12 | Ulrich GmbH & Co. KG | MQP | 04052536178971 |
| Small VBR (ADD) | CS 2250-16-16 | Ulrich GmbH & Co. KG | MQP PLR | 04052536212934 |