GS Medical Co., Ltd.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “GS Medical Co., Ltd.” (first 2006, latest 2026), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 124 days. Since 2017 the median was 98 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 319 |
| 2015 | 0 | — |
| 2016 | 1 | 199 |
| 2017 | 1 | 61 |
| 2018 | 0 | — |
| 2019 | 2 | 100 |
| 2020 | 1 | 157 |
| 2021 | 1 | 140 |
| 2022 | 1 | 47 |
| 2023 | 3 | 124 |
| 2024 | 3 | 64 |
| 2025 | 0 | — |
| 2026 | 1 | 262 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name GS Medical Co., Ltd. took a median 98 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 |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 | 4 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 | 3 |
| NDN | Cement, Bone, Vertebroplasty | 2 | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
Review panels
- Orthopedic (19)
Most recent GS Medical Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254260 | The VEGA Cervical Screw System | NKG | 2026-09-17 | 262 |
| K243073 | AnyPlus Navigated Instruments System | OLO | 2024-12-06 | 70 |
| K241738 | PYXIS 3D Titanium Cervical Cage system | ODP | 2024-08-20 | 64 |
| K240350 | AnyPlus II Spinal Fixation System | NKB | 2024-04-03 | 58 |
| K231808 | QUASAR Standalone ACIF System | OVE | 2023-07-20 | 30 |
| K223868 | PYXIS 3D Titanium Cage System | MAX | 2023-04-26 | 124 |
| K222041 | CYGNUS-C Standalone ACIF System | OVE | 2023-02-09 | 213 |
| K221687 | Pegasus-X Expandable PLIF System | MAX | 2022-07-27 | 47 |
| K211797 | TRACKER Plus Kyphoplasty System | NDN | 2021-10-28 | 140 |
| K200592 | GS Medical AnyPlus PEEK Cage System | ODP | 2020-08-10 | 157 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named GS Medical 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 GS Medical Co., Ltd.?
FDA lists 19 510(k) clearances under the applicant name “GS Medical Co., Ltd.” (first 2006, latest 2026), across 10 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 GS Medical Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name GS Medical Co., Ltd. is 124 days. Since 2017: 98 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under GS Medical Co., Ltd.?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 4); NKB (Thoracolumbosacral Pedicle Screw System, 3); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 3).
Next steps
- See all 19 GS Medical Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MAX, GS Medical 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.