K141246 is an FDA 510(k) clearance for the LIFE SPINE SACROILIAC JOINT FIXATION SYSTEM. This device is classified as a Sacroiliac Joint Fixation (Class II - Special Controls, product code OUR).
Submitted by Life Spine, Inc. (Hoffman Estates, US). The FDA issued a Cleared decision on February 22, 2015, 284 days after receiving the submission on May 14, 2014.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Sacroiliac Joint Fusion.
| 510(k) Number | K141246 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 2014 |
| Decision Date | February 22, 2015 |
| Days to Decision | 284 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | OUR — Sacroiliac Joint Fixation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |
| Definition | Sacroiliac Joint Fusion |