Spinevision, S.A.S.: FDA clearances and approvals
Spinevision, S.A.S. has 5 FDA 510(k) clearances (first 2018, latest 2022), across 2 product codes in 1 review panel. Median 510(k) review time: 73 days. Since 2017 its median was 73 days, against 106 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2018 | 1 | 73 |
| 2019 | 0 | — |
| 2020 | 1 | 358 |
| 2021 | 1 | 30 |
| 2022 | 2 | 111 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Spinevision, S.A.S.'s cleared 510(k)s took a median 73 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 2 |
Review panels
- Orthopedic (5)
Most recent Spinevision, S.A.S. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K223251 | Hexanium PLIF | MAX | 2022-12-16 | 56 |
| K221578 | Hexanium ACIF | OVE | 2022-11-14 | 166 |
| K210359 | Hexanium TLIF | MAX | 2021-03-10 | 30 |
| K193000 | Hexanium® ACIF | OVE | 2020-10-20 | 358 |
| K180437 | Hexanium® TLIF | MAX | 2018-05-04 | 73 |
Recalls
openFDA lists no recalls under a recalling firm named Spinevision, S.A.S..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Spinevision, S.A.S. have?
Spinevision, S.A.S. has 5 FDA 510(k) clearances (first 2018, latest 2022), across 2 product codes in 1 review panel.
How long does FDA take to clear Spinevision, S.A.S.'s 510(k)s?
The median time from FDA receipt to decision across Spinevision, S.A.S.'s cleared 510(k)s is 73 days. Since 2017: 73 days, versus 106 days for all cleared 510(k)s in the same product codes.
What devices does Spinevision, S.A.S. make?
Its most frequent FDA product codes are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 3); OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical, 2).
Has Spinevision, S.A.S. had device recalls?
openFDA lists no recalls under a recalling firm name matching Spinevision, S.A.S. Related entities may recall under other names.
Next steps
- See all 5 Spinevision, S.A.S. clearances with predicates and recalls
- Run predicate analysis for product code MAX, Spinevision, S.A.S.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.