Takiron Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Takiron Co., Ltd.” (first 2007, latest 2008), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 195 days. 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 2 | 2 |
| GWO | Plate, Cranioplasty, Preformed, Alterable | 1 | 1 |
| HTY | Pin, Fixation, Smooth | 1 | 1 |
| JEY | Plate, Bone | 1 | 1 |
| MQV | Filler, Bone Void, Calcium Compound | 1 | 1 |
Review panels
- Orthopedic (4)
- Dental (1)
- Neurology (1)
Most recent Takiron Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081390 | BIOACTIF OSTEOTRANS INTERFENCE SCREW | HWC | 2008-08-12 | 85 |
| K073006 | OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM | GWO | 2008-05-29 | 218 |
| K073312 | OSTEOTRANS-OT SCREW | HWC | 2008-05-13 | 172 |
| K073311 | OSTEOTRANS-OT PIN | HTY | 2008-05-13 | 172 |
| K062691 | COMPORUS | MQV | 2008-04-15 | 582 |
| K061881 | OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM | JEY | 2007-03-14 | 254 |
Recalls
openFDA lists no recalls under a recalling firm named Takiron 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 Takiron Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Takiron Co., Ltd.” (first 2007, latest 2008), across 5 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Takiron Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Takiron Co., Ltd. is 195 days.
Which FDA product codes appear under Takiron Co., Ltd.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 2); GWO (Plate, Cranioplasty, Preformed, Alterable, 1); HTY (Pin, Fixation, Smooth, 1).
Next steps
- See all 6 Takiron Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Takiron 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.