Tdm Co., Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Tdm Co., Ltd.” (first 2018, latest 2024), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 225 days. Since 2017 the median was 225 days, against 91 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 269 |
| 2019 | 2 | 217 |
| 2020 | 1 | 332 |
| 2021 | 0 | — |
| 2022 | 2 | 80 |
| 2023 | 0 | — |
| 2024 | 5 | 225 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Tdm Co., Ltd. took a median 225 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 5 | 5 |
| HWC | Screw, Fixation, Bone | 2 | 2 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
Review panels
- Orthopedic (11)
Most recent Tdm Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241128 | TDM Plate and Screw System | HRS | 2024-12-05 | 225 |
| K230071 | Femur Reconstruction Interlocking Nail System, Femur Retrograde Interlocking Nail System, Humerus Interlocking Nail System, Tibia Interlocking Nail System, Compression Hip Nail System | HSB | 2024-08-22 | 590 |
| K240423 | TDM Anterior Cervical Plate System | KWQ | 2024-04-08 | 55 |
| K232115 | TDM Large Bone Plate and Screw System | HRS | 2024-04-05 | 266 |
| K231860 | TDM Screw System | HWC | 2024-01-18 | 209 |
| K221844 | TDM Lumbar Interbody Fusion Cage System | MAX | 2022-08-17 | 54 |
| K220285 | PINE Pedicle Screw System | NKB | 2022-05-19 | 107 |
| K191057 | Park's Pectus System | HRS | 2020-03-19 | 332 |
| K190391 | TDM Plate and Screw Systems | HRS | 2019-11-15 | 269 |
| K190830 | TDM Screw Systems | HWC | 2019-09-13 | 165 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Tdm Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Tdm Co., Ltd.?
FDA lists 11 510(k) clearances under the applicant name “Tdm Co., Ltd.” (first 2018, latest 2024), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Tdm Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Tdm Co., Ltd. is 225 days. Since 2017: 225 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Tdm Co., Ltd.?
The most frequent FDA product codes under this applicant name are HRS (Plate, Fixation, Bone, 5); HWC (Screw, Fixation, Bone, 2); HSB (Rod, Fixation, Intramedullary And Accessories, 1).
Next steps
- See all 11 Tdm Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HRS, Tdm Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.