Spineway: FDA clearances and approvals
Spineway has 5 FDA 510(k) clearances (first 2015, latest 2023), across 4 product codes in 1 review panel. Median 510(k) review time: 112 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2015 | 3 | 112 |
| 2016 | 0 | — |
| 2017 | 1 | 107 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 125 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Spineway's cleared 510(k)s took a median 116 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 2 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Spineway 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231658 | VEOS Spinal Fixation System | NKB | 2023-10-10 | 125 |
| K162694 | Ayers Rock Cervical interbody fusion system | ODP | 2017-01-12 | 107 |
| K152355 | Twin Peaks Lumbar Interbody Fusion System | MAX | 2015-12-10 | 112 |
| K150185 | Mont Blanc Spinal System | NKB | 2015-05-12 | 105 |
| K150036 | Blue Mountain Cervical Plate System | KWQ | 2015-05-07 | 118 |
Recalls
openFDA lists no recalls under a recalling firm named Spineway.
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 Spineway have?
Spineway has 5 FDA 510(k) clearances (first 2015, latest 2023), across 4 product codes in 1 review panel.
How long does FDA take to clear Spineway's 510(k)s?
The median time from FDA receipt to decision across Spineway's cleared 510(k)s is 112 days.
What devices does Spineway make?
Its most frequent FDA product codes are NKB (Thoracolumbosacral Pedicle Screw System, 2); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 1); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 1).
Has Spineway had device recalls?
openFDA lists no recalls under a recalling firm name matching Spineway. Related entities may recall under other names.
Next steps
- See all 5 Spineway clearances with predicates and recalls
- Run predicate analysis for product code NKB, Spineway'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.