The following data is part of a premarket notification filed by Life Spine Inc. with the FDA for Life Spine Simpact Sacroiliac Joint Fixation System.
| Device ID | K180749 |
| 510k Number | K180749 |
| Device Name: | Life Spine SIMPACT Sacroiliac Joint Fixation System |
| Classification | Sacroiliac Joint Fixation |
| Applicant | Life Spine Inc. 13951 S Quality Drive Huntley, IL 60142 |
| Contact | Randy Lewis |
| Correspondent | Randy Lewis Life Spine Inc. 13951 South Quality Drive Huntley, IL 60142 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-22 |
| Decision Date | 2018-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837096212 | K180749 | 000 |
| 00190837071301 | K180749 | 000 |
| 00190837071295 | K180749 | 000 |
| 00190837071288 | K180749 | 000 |
| 00190837071271 | K180749 | 000 |
| 00190837071264 | K180749 | 000 |
| 00190837071257 | K180749 | 000 |
| 00190837032159 | K180749 | 000 |
| 00190837101572 | K180749 | 000 |
| 00190837101565 | K180749 | 000 |
| 00190837101558 | K180749 | 000 |
| 00190837101541 | K180749 | 000 |
| 00190837101534 | K180749 | 000 |
| 00190837101527 | K180749 | 000 |
| 00190837071318 | K180749 | 000 |
| 00190837079222 | K180749 | 000 |
| 00190837095369 | K180749 | 000 |
| 00190837089245 | K180749 | 000 |
| 00190837089238 | K180749 | 000 |
| 00190837089221 | K180749 | 000 |
| 00190837089214 | K180749 | 000 |
| 00190837089191 | K180749 | 000 |
| 00190837089184 | K180749 | 000 |
| 00190837083946 | K180749 | 000 |
| 00190837079789 | K180749 | 000 |
| 00190837079666 | K180749 | 000 |
| 00190837079659 | K180749 | 000 |
| 00190837079642 | K180749 | 000 |
| 00190837079635 | K180749 | 000 |
| 00190837155902 | K180749 | 000 |