K180213 is an FDA 510(k) clearance for the Titanium TomoFix Medial High Tibia Plate Anatomical. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Synthes USA Products, LLC (West Chester, US). The FDA issued a Cleared decision on October 19, 2018, 267 days after receiving the submission on January 25, 2018.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K180213 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 2018 |
| Decision Date | October 19, 2018 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HRS — Plate, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |