The following data is part of a premarket notification filed by Life Spine, Inc. with the FDA for Simpact Sacroiliac Joint Fixation System.
Device ID | K212903 |
510k Number | K212903 |
Device Name: | 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 | 2021-09-13 |
Decision Date | 2021-12-15 |