Bk Meditech, Co., Ltd.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Bk Meditech, Co., Ltd.” (first 2006, latest 2020), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 119 days. Since 2017 the median was 119 days, against 92 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 |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 338 |
| 2014 | 2 | 223 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 2 | 101 |
| 2019 | 0 | — |
| 2020 | 1 | 119 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Bk Meditech, Co., Ltd. took a median 119 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 2 | 2 |
| JDW | Pin, Fixation, Threaded | 1 | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
| MNI | Orthosis, Spinal Pedicle Fixation | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Review panels
- Orthopedic (11)
Most recent Bk Meditech, Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K200981 | Mega Plus MIS Spine System | NKB | 2020-08-11 | 119 |
| K183080 | Mega Plus Spine System | NKB | 2018-12-10 | 35 |
| K173180 | Mega Plus Spine System | NKB | 2018-03-15 | 167 |
| K140577 | INNESIS PEEK TL CAGE | MAX | 2014-10-01 | 209 |
| K132483 | INNESIS PEEK CERVICAL CAGE | ODP | 2014-04-02 | 237 |
| K120464 | INNESIS PEEK CAGE | MAX | 2013-01-18 | 338 |
| K110426 | DYNA-EXTOR II | KTT | 2011-11-02 | 261 |
| K090424 | DVX SPINE SYSTEM | MNH | 2009-05-14 | 84 |
| K080876 | DVX SPINE SYSTEM | MNH | 2008-06-04 | 65 |
| K072436 | MEGA SPINE SYSTEM | MNI | 2007-11-01 | 63 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Bk Meditech, 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 Bk Meditech, Co., Ltd.?
FDA lists 11 510(k) clearances under the applicant name “Bk Meditech, Co., Ltd.” (first 2006, latest 2020), across 7 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 Bk Meditech, Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bk Meditech, Co., Ltd. is 119 days. Since 2017: 119 days, versus 92 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Bk Meditech, Co., Ltd.?
The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 3); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 2).
Next steps
- See all 11 Bk Meditech, Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NKB, Bk Meditech, 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.