Nexxt Spine, LLC: FDA filings under this applicant name
FDA lists 24 510(k) clearances under the applicant name “Nexxt Spine, LLC” (first 2009, latest 2025), across 13 product codes in 1 review panel. Median 510(k) review time under this name: 60 days. Since 2017 the median was 52 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 |
|---|---|---|
| 2012 | 1 | 131 |
| 2013 | 3 | 57 |
| 2014 | 1 | 30 |
| 2015 | 0 | — |
| 2016 | 1 | 148 |
| 2017 | 1 | 126 |
| 2018 | 1 | 62 |
| 2019 | 2 | 65 |
| 2020 | 7 | 47 |
| 2021 | 0 | — |
| 2022 | 2 | 43 |
| 2023 | 1 | 30 |
| 2024 | 1 | 9 |
| 2025 | 1 | 91 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nexxt Spine, LLC took a median 52 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 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 3 | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 2 | 2 |
| MNI | Orthosis, Spinal Pedicle Fixation | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 2 |
| MRW | System, Facet Screw Spinal Device | 1 | 1 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Plus 3 more product codes.
Review panels
- Orthopedic (24)
Most recent Nexxt Spine, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243838 | NEXXT MATRIXX® SI System | OUR | 2025-03-14 | 91 |
| K240690 | STRUXXURE® MCS Anterior Cervical Plate System | KWQ | 2024-03-22 | 9 |
| K231799 | INERTIA® CONNEXX Modular Pedicle Screw System | NKB | 2023-07-20 | 30 |
| K221905 | INERTIA CONNEXX Modular Pedicle Screw System | NKB | 2022-07-28 | 28 |
| K220291 | NEXXT SPINE NAVIGATION System | OLO | 2022-03-31 | 58 |
| K202230 | NEXXT MATRIXX Stand Alone ALIF System | OVD | 2020-12-15 | 130 |
| K202192 | STRUXXURE®-L and STRUXXURE®-A Plate System | KWQ | 2020-09-17 | 43 |
| K200969 | NEXXT MATRIXX System | MAX | 2020-05-21 | 38 |
| K200543 | NEXXT MATRIXX Stand Alone Cervical-Turn Lock (-TL) System | OVE | 2020-03-23 | 20 |
| K193412 | NEXXT MATRIXX System | PLR | 2020-02-24 | 77 |
14 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Nexxt 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.
- Nexxt Medical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nexxt Spine, LLC?
FDA lists 24 510(k) clearances under the applicant name “Nexxt Spine, LLC” (first 2009, latest 2025), across 13 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 Nexxt Spine, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nexxt Spine, LLC is 60 days. Since 2017: 52 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nexxt Spine, LLC?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 4); KWQ (Appliance, Fixation, Spinal Intervertebral Body, 3); NKB (Thoracolumbosacral Pedicle Screw System, 3).
Next steps
- See all 24 Nexxt Spine, LLC clearances with predicates and recalls
- Run predicate analysis for product code MAX, Nexxt 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.