K190391 is an FDA 510(k) clearance for the TDM Plate and Screw Systems. This device is classified as a Plate, Fixation, Bone (Class II - Special Controls, product code HRS).
Submitted by Tdm Co., Ltd. (Gwangju, KR). The FDA issued a Cleared decision on November 15, 2019, 269 days after receiving the submission on February 19, 2019.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K190391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 19, 2019 |
| Decision Date | November 15, 2019 |
| Days to Decision | 269 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 |