Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Spinevision, S.A.S. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
73 daysmedian FDA review time
358 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K223251 | Hexanium PLIF | Spinevision, S.A.S. | 2022-12-16 | 56 | 0 |
| K221578 | Hexanium ACIF | Spinevision, S.A.S. | 2022-11-14 | 166 | 0 |
| K210359 | Hexanium TLIF | Spinevision, S.A.S. | 2021-03-10 | 30 | 0 |
| K193000 | Hexanium® ACIF | Spinevision, S.A.S. | 2020-10-20 | 358 | 0 |
| K180437 | Hexanium® TLIF | Spinevision, S.A.S. | 2018-05-04 | 73 | 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