Spinevision S.A.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Spinevision S.A.” (first 2012, latest 2016), across 4 product codes in 1 review panel. Median 510(k) review time under this name: 173 days. 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 | 274 |
| 2013 | 1 | 173 |
| 2014 | 1 | 222 |
| 2015 | 0 | — |
| 2016 | 2 | 100 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | 2 | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 | 1 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 1 | 1 |
| NKB | Thoracolumbosacral Pedicle Screw System | 1 | 1 |
Review panels
- Orthopedic (5)
Most recent Spinevision S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153783 | SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF | MAX | 2016-05-04 | 125 |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System | MNI | 2016-04-04 | 75 |
| K133575 | SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. PEDICLE SCREW FIXATION SYSTEM | MNH | 2014-06-30 | 222 |
| K130302 | SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. POLYAXIAL PEDICLE SCREW FIXAT | MNI | 2013-07-30 | 173 |
| K112607 | SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S.(TM) POLYAXIAL PEDICLE ... | NKB | 2012-06-07 | 274 |
Recalls
openFDA lists no recalls under a recalling firm named Spinevision S.A..
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.
- Spinevision, S.A.S. (5 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Spinevision S.A.?
FDA lists 5 510(k) clearances under the applicant name “Spinevision S.A.” (first 2012, latest 2016), 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 Spinevision S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Spinevision S.A. is 173 days.
Which FDA product codes appear under Spinevision S.A.?
The most frequent FDA product codes under this applicant name are MNI (Orthosis, Spinal Pedicle Fixation, 2); MAX (Intervertebral Fusion Device With Bone Graft, Lumbar, 1); MNH (Orthosis, Spondylolisthesis Spinal Fixation, 1).
Next steps
- See all 5 Spinevision S.A. clearances with predicates and recalls
- Run predicate analysis for product code MNI, Spinevision S.A.'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.