Neurostructures, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Neurostructures, Inc.” (first 2012, latest 2020), across 7 product codes in 1 review panel. Median 510(k) review time under this name: 108 days. Since 2017 the median was 108 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 | 2 | 122 |
| 2013 | 1 | 102 |
| 2014 | 1 | 112 |
| 2015 | 1 | 107 |
| 2016 | 1 | 263 |
| 2017 | 2 | 88 |
| 2018 | 6 | 145 |
| 2019 | 1 | 98 |
| 2020 | 4 | 87 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Neurostructures, Inc. 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 90 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 6 | 6 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 3 | 3 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 3 | 3 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 2 | 2 |
| MRW | System, Facet Screw Spinal Device | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
Review panels
- Orthopedic (19)
Most recent Neurostructures, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202190 | Oculus-SA Lumbar Cage System | OVD | 2020-10-02 | 58 |
| K200115 | Cavetto-SA Cervical Cage System | OVE | 2020-09-24 | 247 |
| K201769 | Cavetto [MAX] Cervical Cage System | ODP | 2020-09-03 | 66 |
| K200927 | Transept Cervical Plate System | KWQ | 2020-07-24 | 108 |
| K192248 | Cortina [MAX] Lumbar Cage System | MAX | 2019-11-25 | 98 |
| K182195 | Arco-SA Lumbar Cage System | OVD | 2018-11-09 | 87 |
| K181590 | Neurostructures Cavetto® [MAX] Cervical Cage System | ODP | 2018-11-08 | 143 |
| K173082 | Arco-SA Lumbar Cage System | OVD | 2018-03-29 | 181 |
| K180431 | Cortina [MAX] Lumbar Cage System | MAX | 2018-03-22 | 34 |
| K172320 | Neurostructures Cavetto® Cervical Cage System | ODP | 2018-02-26 | 209 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Neurostructures, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Neurostructures, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Neurostructures, Inc.” (first 2012, latest 2020), 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 Neurostructures, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neurostructures, Inc. is 108 days. Since 2017: 108 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Neurostructures, Inc.?
The most frequent FDA product codes under this applicant name are KWQ (Appliance, Fixation, Spinal Intervertebral Body, 6); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 3); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 3).
Next steps
- See all 19 Neurostructures, Inc. clearances with predicates and recalls
- Run predicate analysis for product code KWQ, Neurostructures, Inc.'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.