Huvexel Co. , Ltd.
Huvexel Co. , Ltd. has 0 FDA recalls, 0 inspections, 8 510(k) clearances and 0 compliance actions on record.
- Latest 510(k)
- Mar 25, 2022
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Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Oct 23, 2026 | Not stated | Current |
| 510(k) clearances | 8 | Oct 4, 2026 | Not stated | Current |
| Inspections | 0 | Oct 23, 2026 | Not stated | Current |
| Compliance actions | 0 | Oct 23, 2026 | Not stated | Current |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K213820 | BALTEUM - ONE Lumbar Plate System | Mar 25, 2022 |
| K200846 | Balteum Lumbar Plate System | May 5, 2020 |
| K191477 | AEON-C Stand Alone System | Nov 13, 2019 |
| K180729 | FaSet Fixation System | Jun 28, 2018 |
| K173201 | UNITY Sacroiliac Joint Fixation System | Apr 26, 2018 |
| K173131 | Rexious Spinal Fixation System | Dec 8, 2017 |
| K173099 | Fortis and Hana Anterior Cervical Plate System | Nov 30, 2017 |
| K173080 | IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) | Oct 31, 2017 |