Silony Medical GmbH: FDA filings under this applicant name
FDA lists 13 510(k) clearances under the applicant name “Silony Medical GmbH” (first 2017, latest 2026), across 5 product codes in 1 review panel. Median 510(k) review time under this name: 150 days. Since 2017 the median was 150 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 |
|---|---|---|
| 2017 | 2 | 176 |
| 2018 | 3 | 150 |
| 2019 | 2 | 194 |
| 2020 | 1 | 253 |
| 2021 | 1 | 45 |
| 2022 | 1 | 16 |
| 2023 | 1 | 199 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 2 | 130 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Silony Medical GmbH took a median 150 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 |
| OLO | Orthopedic Stereotaxic Instrument | 4 | 4 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 | 2 |
| NKG | Posterior Cervical Screw System | 1 | 1 |
Review panels
- Orthopedic (13)
Most recent Silony Medical GmbH 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253921 | VERTICALE® Navigation Instruments | OLO | 2026-06-26 | 200 |
| K254148 | VERTICALE GPS Instruments | OLO | 2026-02-19 | 59 |
| K223806 | VERTICALE® Triangular Fixation System | NKB | 2023-07-06 | 199 |
| K223649 | VERTICALE® Navigation Instruments | OLO | 2022-12-22 | 16 |
| K212007 | VERTICALE Navigation Instruments | OLO | 2021-08-12 | 45 |
| K192013 | VERTICALE® Cervical System | NKG | 2020-04-07 | 253 |
| K190680 | FAVO S-TLIF | MAX | 2019-07-18 | 122 |
| K182608 | Oyster ACIF Cage | ODP | 2019-06-13 | 265 |
| K181899 | ROCCIA® PLIF | MAX | 2018-12-13 | 150 |
| K180963 | ROCCIA ALIF, ROCCIA TLIF | MAX | 2018-07-11 | 90 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Silony Medical GmbH.
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 Silony Medical GmbH is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT06876311: Observational Study to Evaluate the STALIF® C FLX, STALIF® M FLX, STALIF® L FLX Cages and FORTOS-C® (Active not recruiting, started 2025-03-04)
Frequently asked questions
How many FDA 510(k) clearances are listed under Silony Medical GmbH?
FDA lists 13 510(k) clearances under the applicant name “Silony Medical GmbH” (first 2017, latest 2026), across 5 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 Silony Medical GmbH?
The median time from FDA receipt to decision across 510(k)s cleared under the name Silony Medical GmbH is 150 days. Since 2017: 150 days, versus 90 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Silony Medical GmbH?
The most frequent FDA product codes under this applicant name are MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 4); OLO (Orthopedic Stereotaxic Instrument, 4); NKB (Thoracolumbosacral Pedicle Screw System, 2).
Next steps
- See all 13 Silony Medical GmbH clearances with predicates and recalls
- Run predicate analysis for product code MAX, Silony Medical GmbH'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.