K231860 is an FDA 510(k) clearance for the TDM Screw System. This device is classified as a Screw, Fixation, Bone (Class II - Special Controls, product code HWC).
Submitted by Tdm Co., Ltd. (Buk-Gu, KR). The FDA issued a Cleared decision on January 18, 2024, 209 days after receiving the submission on June 23, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K231860 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2023 |
| Decision Date | January 18, 2024 |
| Days to Decision | 209 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | HWC - Screw, Fixation, Bone |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |