Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K201538
Life Spine SIMPACT Sacroiliac Joint Fixation System · Life Spine, Inc. · decided 2020-09-18 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Simpact | 152-14-930 | Life Spine, Inc. | HWC OUR | 00190837119010 |
| Simpact | 152-14-950 | Life Spine, Inc. | HWC OUR | 00190837119058 |
| Simpact | 152-14-935 | Life Spine, Inc. | HWC OUR | 00190837119027 |
| Simpact | 152-14-940 | Life Spine, Inc. | HWC OUR | 00190837119034 |
| Simpact | 152-14-970 | Life Spine, Inc. | HWC | 00190837119096 |
| Simpact | 152-14-965 | Life Spine, Inc. | HWC | 00190837119089 |
| Simpact | 152-14-960 | Life Spine, Inc. | HWC OUR | 00190837119072 |
| Simpact | 152-14-955 | Life Spine, Inc. | HWC OUR | 00190837119065 |
| Simpact | 152-14-945 | Life Spine, Inc. | HWC OUR | 00190837119041 |