K180243 is an FDA 510(k) clearance for the Infinity-Lock Button System. This device is classified as a Washer, Bolt Nut (Class II - Special Controls, product code HTN).
Submitted by Xiros, Ltd. (Leeds, GB). The FDA issued a Cleared decision on April 3, 2018, 64 days after receiving the submission on January 29, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K180243 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 29, 2018 |
| Decision Date | April 03, 2018 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HTN - Washer, Bolt Nut |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |