Nanovis, LLC: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “Nanovis, LLC” (first 2011, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 94 days. Since 2017 the median was 93 days, against 91 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 | 84 |
| 2013 | 0 | — |
| 2014 | 1 | 213 |
| 2015 | 0 | — |
| 2016 | 2 | 94 |
| 2017 | 0 | — |
| 2018 | 1 | 263 |
| 2019 | 1 | 95 |
| 2020 | 1 | 29 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 60 |
| 2024 | 1 | 93 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Nanovis, LLC took a median 93 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 4 | 4 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 4 | 4 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 2 |
Review panels
- Orthopedic (10)
Most recent Nanovis, LLC 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241605 | Adaptix PEEK Interbody System with Nanotechnology; Capstone Control PEEK Spinal System with Nanotechnology | MAX | 2024-09-05 | 93 |
| K230936 | Anatomic PEEK Cervical Fusion System with Nanotechnology | ODP | 2023-06-02 | 60 |
| K203452 | Nano FortiFix® System | NKB | 2020-12-22 | 29 |
| K191822 | Nano FortiCore, FortiCore | ODP | 2019-10-11 | 95 |
| K171312 | FortiCore® | MAX | 2018-01-22 | 263 |
| K161485 | Nanovis Intervertebral Body Fusion System and Forticore(R) | MAX | 2016-09-06 | 98 |
| K160874 | Nanovis Intervertebral Body Fusion System and FortiCore® | MAX | 2016-06-28 | 90 |
| K140280 | FORTICORE | ODP | 2014-09-05 | 213 |
| K113173 | NANOVIS SPINAL SYSTEM | NKB | 2012-01-19 | 84 |
| K110442 | NANOVIS INTERVERTEBRAL BODY FUSION SYSTEM | ODP | 2011-11-09 | 266 |
Recalls
openFDA lists no recalls under a recalling firm named Nanovis, 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.
- Nanovis Spine, LLC (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Nanovis, LLC?
FDA lists 10 510(k) clearances under the applicant name “Nanovis, LLC” (first 2011, latest 2024), across 3 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 Nanovis, LLC?
The median time from FDA receipt to decision across 510(k)s cleared under the name Nanovis, LLC is 94 days. Since 2017: 93 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Nanovis, LLC?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 4); ODP (Intervertebral Fusion Device With Bone Graft, Cervical, 4); NKB (Thoracolumbosacral Pedicle Screw System, 2).
Next steps
- See all 10 Nanovis, LLC clearances with predicates and recalls
- Run predicate analysis for product code MAX, Nanovis, 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.