Clariance, Sas: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Clariance, Sas” (first 2016, latest 2021), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 100 days. Since 2017 the median was 100 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 |
|---|---|---|
| 2016 | 2 | 88 |
| 2017 | 3 | 121 |
| 2018 | 0 | — |
| 2019 | 3 | 87 |
| 2020 | 1 | 53 |
| 2021 | 2 | 201 |
| 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 Clariance, Sas took a median 100 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 |
|---|---|---|---|
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 4 | 4 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 | 3 |
| NKB | Thoracolumbosacral Pedicle Screw System | 3 | 3 |
| OLO | Orthopedic Stereotaxic Instrument | 1 | 1 |
Review panels
- Orthopedic (11)
Most recent Clariance, Sas 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K202032 | Idys LLIF 3DTi | OVD | 2021-04-01 | 253 |
| K202956 | Erisma LP Navigated Instruments | OLO | 2021-02-26 | 149 |
| K200920 | Idys ALIF ZP 3DTi | MAX | 2020-05-29 | 53 |
| K192168 | Idys ALIF ZP 3DTi | OVD | 2019-11-04 | 87 |
| K191263 | Idys ALIF TiVac | OVD | 2019-06-06 | 27 |
| K183259 | Idys TLIF TiVac | MAX | 2019-03-01 | 100 |
| K172465 | Idys TLIF 3DTi Cages | MAX | 2017-12-15 | 123 |
| K172083 | Idys ALIF System | OVD | 2017-11-08 | 121 |
| K170163 | Erisma® LP Spinal Fixation System | NKB | 2017-02-14 | 27 |
| K162367 | Erisma® LP MIS | NKB | 2016-10-27 | 65 |
1 earlier clearances. See the full list in Caduvo.
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2026-02-20.
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.
- Clariance (10 510(k)s)
- Clariance, SA (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Clariance, Sas?
FDA lists 11 510(k) clearances under the applicant name “Clariance, Sas” (first 2016, latest 2021), across 4 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 Clariance, Sas?
The median time from FDA receipt to decision across 510(k)s cleared under the name Clariance, Sas is 100 days. Since 2017: 100 days, versus 91 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Clariance, Sas?
The most frequent FDA product codes under this applicant name are OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar, 4); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 3); NKB (Thoracolumbosacral Pedicle Screw System, 3).
Next steps
- See all 11 Clariance, Sas clearances with predicates and recalls
- Run predicate analysis for product code OVD, Clariance, Sas'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.