K190774 is an FDA 510(k) clearance for the RIGIDLOOP Titanium Button , RIGIDLOOP Cortical Fixation System XL Implant. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).
Submitted by Medos International SARL (Le Locle, CH). The FDA issued a Cleared decision on July 25, 2019, 121 days after receiving the submission on March 26, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K190774 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 26, 2019 |
| Decision Date | July 25, 2019 |
| Days to Decision | 121 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBI — Fastener, Fixation, Nondegradable, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |