K182789 is an FDA 510(k) clearance for the KLS Martin Individual Patient Solutions (IPS) Planning System. This device is classified as a Driver, Wire, And Bone Drill, Manual (Class II - Special Controls, product code DZJ).
Submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on March 11, 2019, 161 days after receiving the submission on October 1, 2018.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K182789 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 01, 2018 |
| Decision Date | March 11, 2019 |
| Days to Decision | 161 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | DZJ — Driver, Wire, And Bone Drill, Manual |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |