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 | K201538 |
| 510k Number | K201538 |
| 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 | Angela Batker |
| Correspondent | Angela Batker Life Spine Inc. 13951 S 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 | 2020-06-09 |
| Decision Date | 2020-09-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190837119072 | K201538 | 000 |
| 00190837119065 | K201538 | 000 |
| 00190837119058 | K201538 | 000 |
| 00190837119041 | K201538 | 000 |
| 00190837119034 | K201538 | 000 |
| 00190837119027 | K201538 | 000 |
| 00190837119010 | K201538 | 000 |
| 00190837119096 | K201538 | 000 |
| 00190837119089 | K201538 | 000 |