Huvexel Co. , Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Huvexel Co. , Ltd.” (first 2017, latest 2022), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 85 days. Since 2017 the median was 85 days, against 88 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 |
|---|---|---|
| 2017 | 3 | 62 |
| 2018 | 2 | 153 |
| 2019 | 1 | 162 |
| 2020 | 1 | 35 |
| 2021 | 0 | — |
| 2022 | 1 | 107 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Huvexel Co. , Ltd. took a median 85 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 | 3 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| MRW | System, Facet Screw Spinal Device | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
| OUR | Sacroiliac Joint Fixation | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
Review panels
- Orthopedic (8)
Most recent Huvexel Co. , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K213820 | BALTEUM - ONE Lumbar Plate System | KWQ | 2022-03-25 | 107 |
| K200846 | Balteum Lumbar Plate System | KWQ | 2020-05-05 | 35 |
| K191477 | AEON-C Stand Alone System | OVE | 2019-11-13 | 162 |
| K180729 | FaSet Fixation System | MRW | 2018-06-28 | 100 |
| K173201 | UNITY Sacroiliac Joint Fixation System | OUR | 2018-04-26 | 206 |
| K173131 | Rexious Spinal Fixation System | NKB | 2017-12-08 | 70 |
| K173099 | Fortis and Hana Anterior Cervical Plate System | KWQ | 2017-11-30 | 62 |
| K173080 | IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) | MAX | 2017-10-31 | 32 |
Recalls
openFDA lists no recalls under a recalling firm named Huvexel 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 Huvexel Co. , Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Huvexel Co. , Ltd.” (first 2017, latest 2022), across 6 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 Huvexel Co. , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Huvexel Co. , Ltd. is 85 days. Since 2017: 85 days, versus 88 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Huvexel Co. , Ltd.?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 3); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 1); MRW (System, Facet Screw Spinal Device, 1).
Next steps
- See all 8 Huvexel Co. , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Huvexel 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.