K180818 is an FDA 510(k) clearance for the Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System). This device is classified as a Sacroiliac Joint Fixation (Class II - Special Controls, product code OUR).
Submitted by Tenon Medical, Inc. (San Ramon, US). The FDA issued a Cleared decision on June 13, 2018, 76 days after receiving the submission on March 29, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040. Sacroiliac Joint Fusion.
| 510(k) Number | K180818 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 29, 2018 |
| Decision Date | June 13, 2018 |
| Days to Decision | 76 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 |