Spineart SA: FDA clearances and approvals
Spineart SA has 14 FDA 510(k) clearances (first 2019, latest 2026), across 7 product codes in 1 review panel. Median 510(k) review time: 108 days. Since 2017 its median was 108 days, against 92 days for all cleared 510(k)s in the same product codes. openFDA lists 13 product recalls by a recalling firm named Spineart SA.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2019 | 1 | 166 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 107 |
| 2024 | 4 | 59 |
| 2025 | 2 | 216 |
| 2026 | 5 | 108 |
Review time against the same product codes
Since 2017, Spineart SA's cleared 510(k)s took a median 108 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 92 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 6 | 6 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 | 1 |
| QLQ | Manual Instruments Designed For Use With Total Disc Replacement Devices | 1 | 1 |
Review panels
- Orthopedic (14)
Most recent Spineart SA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261049 | SCALA® TL | MAX | 2026-08-20 | 142 |
| K262639 | BAGUERA® C Cervical Disc Surgical Instruments | QLQ | 2026-08-14 | 16 |
| K261205 | SPINEART Navigation Instrument System | OLO | 2026-07-29 | 107 |
| K253966 | PERLA® TL Posterior Thoraco-lumbar Fixation System | NKB | 2026-05-01 | 141 |
| K254158 | SPINEART Navigation Instrument System | OLO | 2026-04-09 | 108 |
| K242933 | SPINEART Navigation Instrument System | OLO | 2025-06-18 | 266 |
| K242890 | SPINEART Navigation Instrument System | OLO | 2025-03-07 | 165 |
| K242589 | Scarlet® AL-T | MAX | 2024-10-23 | 54 |
| K241644 | SPINEART Navigation Instrument System | OLO | 2024-08-07 | 61 |
| K241321 | Juliet® Ti LL Lumbar Interbody Device | OVD | 2024-07-18 | 69 |
4 earlier clearances. See the full list in Caduvo.
Recalls
13 product recalls in 6 recall events; 4 initiated in the last five years. Most recent: 2025-06-30.
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 Spineart SA have?
Spineart SA has 14 FDA 510(k) clearances (first 2019, latest 2026), across 7 product codes in 1 review panel.
How long does FDA take to clear Spineart SA's 510(k)s?
The median time from FDA receipt to decision across Spineart SA's cleared 510(k)s is 108 days. Since 2017: 108 days, versus 92 days for all cleared 510(k)s in the same product codes.
What devices does Spineart SA make?
Its most frequent FDA product codes are OLO (Orthopedic Stereotaxic Instrument, 6); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2); NKB (Thoracolumbosacral Pedicle Screw System, 2).
Has Spineart SA had device recalls?
openFDA lists 13 product recalls in 6 recall events by a recalling firm whose name matches Spineart SA; the most recent began 2025-06-30. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 14 Spineart SA clearances with predicates and recalls
- Run predicate analysis for product code OLO, Spineart SA'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.