Solco Biomedical Co., Ltd.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Solco Biomedical Co., Ltd.” (first 2005, latest 2024), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 148 days. Since 2017 the median was 174 days, against 90 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 | 1 | 75 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 174 |
| 2018 | 0 | — |
| 2019 | 4 | 144 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 576 |
| 2023 | 0 | — |
| 2024 | 1 | 539 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Solco Biomedical Co., Ltd. took a median 174 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 6 | 6 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| MNI | Orthosis, Spinal Pedicle Fixation | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| HRS | Plate, Fixation, Bone | 1 | 1 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
Review panels
- Orthopedic (17)
Most recent Solco Biomedical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231655 | 4CIS® Chiron Spinal Fixation System | NKB | 2024-11-26 | 539 |
| K203233 | 4CIS Chiron Spinal Fixation System | NKB | 2022-06-01 | 576 |
| K192044 | 4CIS Marlin PEEK ACIF Cage | ODP | 2019-12-19 | 141 |
| K190563 | 4CIS PEEK PLIF Cage, 4CIS Pebble Beach PEEK PLIF Cage, 4CIS Torrey Pines PEEK TLIF Cage, 4CIS Dunes PEEK DLIF Cage, 4CIS Augusta PEEK ALIF Cage | MAX | 2019-09-18 | 197 |
| K190471 | 4CIS® Chiron Spinal Fixation System | NKB | 2019-07-24 | 148 |
| K182489 | 4CIS® Pinehurst Anterior Cervical Plate system | KWQ | 2019-01-16 | 127 |
| K162402 | 4CIS® Marlin ACIF Cage System | ODP | 2017-02-16 | 174 |
| K121615 | 4CIS VANE SPINE SYSTEM | MNI | 2012-08-15 | 75 |
| K102458 | 4CIS SOLAR SPINE SYSTEM AND 4CIS APOLLON SPINE SYSTEM | MNH | 2011-06-13 | 290 |
| K101818 | 4CIS VANE SPINE SYSTEM | MNH | 2011-02-11 | 226 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Solco Biomedical 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Solco Basle, Inc. (10 510(k)s)
- Solco Biomedical Company India Private Limited (2 510(k)s)
- Solco Biomedical Copany India Private Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Solco Biomedical Co., Ltd.?
FDA lists 17 510(k) clearances under the applicant name “Solco Biomedical Co., Ltd.” (first 2005, latest 2024), 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 Solco Biomedical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Solco Biomedical Co., Ltd. is 148 days. Since 2017: 174 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Solco Biomedical Co., Ltd.?
The most frequent FDA product codes under this applicant name are MNH (Orthosis, Spondylolisthesis Spinal Fixation, 6); NKB (Thoracolumbosacral Pedicle Screw System, 3); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2).
Next steps
- See all 17 Solco Biomedical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MNH, Solco Biomedical 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.