Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K162496
Foundation 3D Interbody · Corelink, LLC · decided 2017-05-04 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| ZAVATION SIZER | 29-151306-12 | Zavation LLC | ODP | 00197157078409 |
| ZAVATION SIZER | 29-151306-09 | Zavation LLC | ODP | 00197157078379 |
| ZAVATION SIZER | 29-151306-05 | Zavation LLC | ODP | 00197157078331 |
| ZAVATION TRIAL | 02T01012 | Zavation LLC | MAX | 00197157077532 |
| ZAVATION TRIAL | 02P00080 | Zavation LLC | MAX | 00197157056605 |
| ZAVATION TRIAL | 8718-814 | Zavation LLC | MAX | 00197157077990 |
| ZAVATION SIZER | 29-141206-10 | Zavation LLC | ODP | 00197157078140 |
| ZAVATION TRIAL | 02T01001 | Zavation LLC | MAX | 00197157077426 |
| ZAVATION TRIAL | 8722-812 | Zavation LLC | MAX | 00197157078072 |
| ZAVATION TRIAL | 02T01009 | Zavation LLC | MAX | 00197157077501 |
| ZAVATION INSTRUMENT TRAY | 14T00928 | Zavation LLC | MAX | 00197157068455 |
| ZAVATION TRIAL | 02P01231 | Zavation LLC | MAX | 00197157056988 |
| ZAVATION TRIAL | 02P01346 | Zavation LLC | MAX | 00197157057015 |
| ZAVATION TRIAL | 02P00095 | Zavation LLC | MAX | 00197157056759 |
| ZAVATION TRIAL | 02P01347 | Zavation LLC | MAX | 00197157057022 |
| ZAVATION SIZER | 29-141200-06 | Zavation LLC | ODP | 00197157078263 |
| ZAVATION SIZER | 29-141206-12 | Zavation LLC | ODP | 00197157078164 |
| ZAVATION SIZER | 29-141200-05 | Zavation LLC | ODP | 00197157078256 |
| ZAVATION SIZER | 29-141206-11 | Zavation LLC | ODP | 00197157078157 |
| ZAVATION TRIAL | 02P01348 | Zavation LLC | MAX | 00197157057039 |
| ZAVATION TRIAL | 02T01026 | Zavation LLC | MAX | 00197157077679 |
| ZAVATION TRIAL | 02T01032 | Zavation LLC | MAX | 00197157077730 |
| ZAVATION TRIAL | 8722-806 | Zavation LLC | MAX | 00197157078041 |
| ZAVATION INSTRUMENT TRAY | 14T00915 | Zavation LLC | MAX | 00197157068349 |
| ZAVATION INSTRUMENT TRAY | 14T00921 | Zavation LLC | MAX | 00197157068394 |