Neo Medical SA: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Neo Medical SA” (first 2017, latest 2024), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 92 days. Since 2017 the median was 92 days, against 89 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 |
|---|---|---|
| 2017 | 1 | 104 |
| 2018 | 0 | — |
| 2019 | 2 | 224 |
| 2020 | 0 | — |
| 2021 | 1 | 80 |
| 2022 | 1 | 30 |
| 2023 | 0 | — |
| 2024 | 1 | 24 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Neo Medical SA took a median 92 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 89 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 2 |
| PML | Bone Cement, Posterior Screw Augmentation | 2 | 2 |
Review panels
- Orthopedic (6)
Most recent Neo Medical SA 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243693 | NEO Pedicle Screw System | NKB | 2024-12-23 | 24 |
| K222256 | BonOs® Inject Bone Cement; NEO Pedicle Screw System | PML | 2022-08-26 | 30 |
| K212489 | BonOs Inject Bone Cement; NEO Pedicle Screw System | PML | 2021-10-28 | 80 |
| K191796 | Neo Cage System | MAX | 2019-12-13 | 163 |
| K181048 | Neo Cage System TM | MAX | 2019-01-29 | 285 |
| K171582 | NEO Pedicle Screw System | NKB | 2017-09-12 | 104 |
Recalls
openFDA lists no recalls under a recalling firm named Neo Medical SA.
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.
Device clinical trials
An industry sponsor named Neo Medical SA is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT03956537: PMCF Neo Pedicle Screw and Cage Systems (Active not recruiting, started 2019-10-15)
Frequently asked questions
How many FDA 510(k) clearances are listed under Neo Medical SA?
FDA lists 6 510(k) clearances under the applicant name “Neo Medical SA” (first 2017, 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 Neo Medical SA?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neo Medical SA is 92 days. Since 2017: 92 days, versus 89 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Neo Medical SA?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 2); NKB (Thoracolumbosacral Pedicle Screw System, 2); PML (Bone Cement, Posterior Screw Augmentation, 2).
Next steps
- See all 6 Neo Medical SA clearances with predicates and recalls
- Run predicate analysis for product code MAX, Neo Medical SA'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.