Bm Korea Co., Ltd.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Bm Korea Co., Ltd.” (first 2011, latest 2015), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 173 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 | 2 | 176 |
| 2013 | 1 | 182 |
| 2014 | 0 | — |
| 2015 | 2 | 163 |
| 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 |
|---|---|---|---|
| NDN | Cement, Bone, Vertebroplasty | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
Review panels
- Orthopedic (6)
Most recent Bm Korea Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K143110 | GALAXY MIS Screw System | NKB | 2015-06-24 | 238 |
| K143006 | GUARDIAN-SG Inflatable Bone Expander System | NDN | 2015-01-16 | 88 |
| K122518 | SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE | ODP | 2013-02-15 | 182 |
| K120353 | SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM | MNH | 2012-05-09 | 93 |
| K111820 | SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE | ODP | 2012-03-14 | 260 |
| K111593 | GUARDIAN INFLATABLE BONE EXPANDER SYSTEM | NDN | 2011-11-18 | 164 |
Recalls
openFDA lists no recalls under a recalling firm named Bm Korea 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 Bm Korea Co., Ltd.?
FDA lists 6 510(k) clearances under the applicant name “Bm Korea Co., Ltd.” (first 2011, latest 2015), across 4 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 Bm Korea Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Bm Korea Co., Ltd. is 173 days.
Which FDA product codes appear under Bm Korea Co., Ltd.?
The most frequent FDA product codes under this applicant name are NDN (Cement, Bone, Vertebroplasty, 2); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 2); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 1).
Next steps
- See all 6 Bm Korea Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NDN, Bm Korea 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.