Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tdm Co., Ltd. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
225 daysmedian FDA review time
332 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241128 | TDM Plate and Screw System | Tdm Co., Ltd. | 2024-12-05 | 225 | 0 |
| K230071 | Femur Reconstruction Interlocking Nail System, Femur Retrogr | Tdm Co., Ltd. | 2024-08-22 | 590 | 0 |
| K240423 | TDM Anterior Cervical Plate System | Tdm Co., Ltd. | 2024-04-08 | 55 | 0 |
| K232115 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | 2024-04-05 | 266 | 0 |
| K231860 | TDM Screw System | Tdm Co., Ltd. | 2024-01-18 | 209 | 0 |
| K221844 | TDM Lumbar Interbody Fusion Cage System | Tdm Co., Ltd. | 2022-08-17 | 54 | 0 |
| K220285 | PINE Pedicle Screw System | Tdm Co., Ltd. | 2022-05-19 | 107 | 0 |
| K191057 | Park's Pectus System | Tdm Co., Ltd. | 2020-03-19 | 332 | 0 |
| K190391 | TDM Plate and Screw Systems | Tdm Co., Ltd. | 2019-11-15 | 269 | 0 |
| K190830 | TDM Screw Systems | Tdm Co., Ltd. | 2019-09-13 | 165 | 0 |
| K171808 | TDM Plate and Screw System | Tdm Co., Ltd. | 2018-03-15 | 269 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda