Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Huvexel Co. , Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
100 daysmedian FDA review time
206 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213820 | BALTEUM - ONE™ Lumbar Plate System | Huvexel Co. , Ltd. | 2022-03-25 | 107 | 0 |
| K200846 | Balteum™ Lumbar Plate System | Huvexel Co. , Ltd. | 2020-05-05 | 35 | 0 |
| K191477 | AEON-C Stand Alone System | Huvexel Co. , Ltd. | 2019-11-13 | 162 | 0 |
| K180729 | FaSet Fixation System | Huvexel Co. , Ltd. | 2018-06-28 | 100 | 0 |
| K173201 | UNITY Sacroiliac Joint Fixation System | Huvexel Co. , Ltd. | 2018-04-26 | 206 | 0 |
| K173131 | Rexious Spinal Fixation System | Huvexel Co. , Ltd. | 2017-12-08 | 70 | 0 |
| K173099 | Fortis and Hana Anterior Cervical Plate System | Huvexel Co. , Ltd. | 2017-11-30 | 62 | 0 |
| K173080 | IVA Cage Ti (ACIF, PLIF, TLIF, DLIF, and ALIF) | Huvexel Co. , Ltd. | 2017-10-31 | 32 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda