Recognized a 510(k)/PMA number — showing its clearance record and devices.
Clearance record K180749
Life Spine SIMPACT Sacroiliac Joint Fixation System · Life Spine, Inc. · decided 2018-06-15 (SESE)
Devices
| Brand | Model | Company | Product codes | Primary DI |
|---|---|---|---|---|
| Simpact | 114-342-1 | Life Spine, Inc. | OUR | 00190837071288 |
| Simpact | 114-342-2 | Life Spine, Inc. | OUR | 00190837071295 |
| Simpact | 152-08-635 | Life Spine, Inc. | OUR | 00190837101527 |
| Simpact | 152-152 | Life Spine, Inc. | OUR | 00190837079666 |
| Simpact | 152-08-655 | Life Spine, Inc. | OUR | 00190837101565 |
| Simpact | 152-166 | Life Spine, Inc. | OUR | 00190837089191 |
| Simpact | 152-08-640 | Life Spine, Inc. | OUR | 00190837101534 |
| Simpact | 152-190 | Life Spine, Inc. | OUR | 00190837089221 |
| Simpact | 152-192 | Life Spine, Inc. | OUR | 00190837089245 |
| Simpact | 152-151 | Life Spine, Inc. | OUR | 00190837079659 |
| Simpact | 152-08-645 | Life Spine, Inc. | OUR | 00190837101541 |
| Simpact | 2022-0034 | Life Spine, Inc. | OUR | 00190837155902 |
| Simpact | 152-102 | Life Spine, Inc. | OUR | 00190837079635 |
| Simpact | 112-360 | Life Spine, Inc. | OUR | 00190837071257 |
| Simpact | 114-341-2 | Life Spine, Inc. | OUR | 00190837071271 |
| Simpact | 152-100 | Life Spine, Inc. | OUR | 00190837089184 |
| Simpact Instrument | 2019-0071 | Life Spine, Inc. | OUR | 00190837079789 |
| Simpact Instruments | 2019-0004 | Life Spine, Inc. | OUR | 00190837032159 |
| Simpact | 114-341-1 | Life Spine, Inc. | OUR | 00190837071264 |
| Simpact | 152-107 | Life Spine, Inc. | OUR | 00190837079642 |
| Simpact | 152-08-650 | Life Spine, Inc. | OUR | 00190837101558 |
| Simpact Custom | 2019-0085 | Life Spine, Inc. | OUR | 00190837096212 |
| Simpact | 114-343-1 | Life Spine, Inc. | OUR | 00190837071318 |
| Simpact | 152-189 | Life Spine, Inc. | OUR | 00190837089214 |
| Simpact | 2019-0083 | Life Spine, Inc. | OUR | 00190837095369 |