Spineart: FDA clearances and approvals
Spineart has 44 FDA 510(k) clearances (first 2008, latest 2023), across 13 product codes in 2 review panels. Median 510(k) review time: 70 days. Since 2017 its median was 59 days, against 90 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 59 |
| 2013 | 1 | 116 |
| 2014 | 8 | 70 |
| 2015 | 2 | 92 |
| 2016 | 5 | 161 |
| 2017 | 2 | 80 |
| 2018 | 4 | 72 |
| 2019 | 3 | 41 |
| 2020 | 5 | 60 |
| 2021 | 2 | 38 |
| 2022 | 1 | 85 |
| 2023 | 1 | 94 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Spineart's cleared 510(k)s took a median 59 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 10 | 10 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 5 | 5 |
| MNI | Orthosis, Spinal Pedicle Fixation | 5 | 5 |
| NKB | Thoracolumbosacral Pedicle Screw System | 5 | 5 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 5 | 5 |
| NKG | Posterior Cervical Screw System | 3 | 3 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 3 | 3 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 2 |
| GAD | Retractor | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Spineart 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230774 | PERLA® TL System; TEKTONA® HV US Bone Cement | PML | 2023-06-23 | 94 |
| K213470 | PERLA® TL Posterior Osteosynthesis System | NKB | 2022-01-21 | 85 |
| K210472 | SPINEART Navigation Instrument System | OLO | 2021-03-19 | 30 |
| K203506 | PERLA® TL posterior osteosynthesis system | NKB | 2021-01-15 | 46 |
| K203222 | PERLA TL Posterior Osteosynthesis System | NKB | 2020-12-17 | 45 |
| K200571 | PERLA® Posterior Occipito-Cervico-Thoracic Fixation System | NKG | 2020-05-01 | 58 |
| K200312 | Tryptik Ti | ODP | 2020-04-06 | 60 |
| K193396 | PERLA® TL posterior osteosynthesis system | NKB | 2020-02-05 | 61 |
| K192993 | SCARLET AL-T | OVD | 2020-01-22 | 89 |
| K190877 | Juliet® Ti LL Lumbar Interbody Device | OVD | 2019-05-29 | 55 |
34 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Spineart.
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 have?
Spineart has 44 FDA 510(k) clearances (first 2008, latest 2023), across 13 product codes in 2 review panels.
How long does FDA take to clear Spineart's 510(k)s?
The median time from FDA receipt to decision across Spineart's cleared 510(k)s is 70 days. Since 2017: 59 days, versus 90 days for all cleared 510(k)s in the same product codes.
What devices does Spineart make?
Its most frequent FDA product codes are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 10); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 5); MNI (Orthosis, Spinal Pedicle Fixation, 5).
Has Spineart had device recalls?
openFDA lists no recalls under a recalling firm name matching Spineart. Related entities may recall under other names.
Next steps
- See all 44 Spineart clearances with predicates and recalls
- Run predicate analysis for product code MAX, Spineart'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.