Neos Surgery S.L: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Neos Surgery S.L” (first 2010, latest 2024), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 105 days. Since 2017 the median was 120 days, against 123 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 | 0 | — |
| 2013 | 1 | 90 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 87 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 179 |
| 2023 | 0 | — |
| 2024 | 1 | 29 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Neos Surgery S.L took a median 120 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 123 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXR | Cover, Burr Hole | 4 | 4 |
| JDQ | Cerclage, Fixation | 2 | 2 |
Review panels
- Neurology (4)
- Orthopedic (2)
Most recent Neos Surgery S.L 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K240137 | Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System | GXR | 2024-02-16 | 29 |
| K221795 | STERN FIX Sternal Stabilization System | JDQ | 2022-10-19 | 120 |
| K211613 | Stern Fix Sternal Stabilization System | JDQ | 2022-01-19 | 238 |
| K160739 | Cranial COVER | GXR | 2016-06-12 | 87 |
| K132044 | CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTEM | GXR | 2013-09-30 | 90 |
| K101235 | CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM | GXR | 2010-10-25 | 175 |
Recalls
openFDA lists no recalls under a recalling firm named Neos Surgery S.L.
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 Neos Surgery S.L?
FDA lists 6 510(k) clearances under the applicant name “Neos Surgery S.L” (first 2010, latest 2024), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Neos Surgery S.L?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neos Surgery S.L is 105 days. Since 2017: 120 days, versus 123 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Neos Surgery S.L?
The most frequent FDA product codes under this applicant name are GXR (Cover, Burr Hole, 4); JDQ (Cerclage, Fixation, 2).
Next steps
- See all 6 Neos Surgery S.L clearances with predicates and recalls
- Run predicate analysis for product code GXR, Neos Surgery S.L'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.