Nexus Spine, LLC: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Nexus Spine, LLC” (first 2014, latest 2026), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 86 days. Since 2017 the median was 83 days, against 90 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 123 |
| 2015 | 0 | — |
| 2016 | 1 | 96 |
| 2017 | 1 | 147 |
| 2018 | 3 | 86 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 221 |
| 2023 | 6 | 62 |
| 2024 | 3 | 55 |
| 2025 | 2 | 72 |
| 2026 | 1 | 66 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nexus Spine, LLC took a median 83 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 | 4 | 4 |
| NKB | Thoracolumbosacral Pedicle Screw System | 4 | 4 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 | 4 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 4 | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
Review panels
- Orthopedic (19)
Most recent Nexus Spine, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261279 | DeltaNEC Interbody System | OVE | 2026-06-22 | 66 |
| K253331 | PressON Spinal Fixation System | NKB | 2025-10-14 | 14 |
| K243934 | Stable-L Lumbar Interbody System | OVD | 2025-04-30 | 131 |
| K241467 | Stable-C Interbody System | OVE | 2024-07-17 | 55 |
| K233375 | Tranquil-L Interbody System | MAX | 2024-03-20 | 170 |
| K240416 | Tranquil-C Interbody System | ODP | 2024-03-12 | 29 |
| K233234 | PressON Spinal Fixation System | NKB | 2023-10-26 | 28 |
| K231486 | Stable-L Standalone Lumbar Interbody System | OVD | 2023-10-12 | 142 |
| K232530 | Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System | OVD | 2023-09-18 | 28 |
| K231763 | Stable-C Interbody System | OVE | 2023-08-21 | 66 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nexus Spine, LLC.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Nexus Medical, LLC (16 510(k)s)
- Nexus Co. , Ltd. C/O Yama Trans Co. , Ltd. (3 510(k)s)
- Nexus Health Care Products , Ltd. (1 510(k)s)
- Nexus CMF, LLC (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nexus Spine, LLC?
FDA lists 19 510(k) clearances under the applicant name “Nexus Spine, LLC” (first 2014, latest 2026), across 7 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Nexus Spine, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nexus Spine, LLC is 86 days. Since 2017: 83 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nexus Spine, LLC?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 4); NKB (Thoracolumbosacral Pedicle Screw System, 4); OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 4).
Next steps
- See all 19 Nexus Spine, LLC clearances with predicates and recalls
- Run predicate analysis for product code MAX, Nexus Spine, LLC's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.