Integra Neurosciences Implants S.A.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Integra Neurosciences Implants S.A.” (first 2003, latest 2008), across 1 product code in 1 review panel. Median 510(k) review time under this name: 24 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Integra LifeSciences, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 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 |
|---|---|---|---|
| JXG | Shunt, Central Nervous System And Components | 6 | 6 |
Review panels
- Neurology (6)
Most recent Integra Neurosciences Implants S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K081773 | OSV II | JXG | 2008-11-06 | 136 |
| K042558 | EQUI-FLOW VALVE AND SHUNT SYSTEM | JXG | 2004-10-06 | 15 |
| K042192 | LOW FLOW OSV II HYDROCEPHALUS VALVE | JXG | 2004-09-02 | 21 |
| K040201 | MODIFICATION TO BURR HOLE VALVE AND SHUNT SYSTEM | JXG | 2004-02-26 | 28 |
| K033698 | CONTOUR-FLEX VALVE AND SHUNT SYSTEM | JXG | 2003-12-17 | 22 |
| K032817 | EXTERNAL DRAINAGE SET | JXG | 2003-10-06 | 26 |
Recalls
openFDA lists no recalls under a recalling firm named Integra Neurosciences Implants 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.
- Integra LifeSciences Corporation (94 510(k)s)
- Integra Neurocare, LLC (12 510(k)s)
- Integra Radionics, Inc. (10 510(k)s)
- Integra Lifesciences Production Corporation (9 510(k)s)
- Integra Neurosciences (8 510(k)s)
- Integra Life Sciences (3 510(k)s)
- Integra Lifescience Corportation (2 510(k)s)
- Integra Medical (2 510(k)s)
- Integra Biotechnical, LLC (1 510(k)s)
- Integra Burlington Ma, Inc. (1 510(k)s)
- Integra Burlington Ma, Inc. (Formerly Integra Radi (1 510(k)s)
- Integra Lifesciences Corporation (Owner of Tei Biosciences) (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Integra Neurosciences Implants S.A.?
FDA lists 6 510(k) clearances under the applicant name “Integra Neurosciences Implants S.A.” (first 2003, latest 2008), across 1 product code 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 Integra Neurosciences Implants S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Integra Neurosciences Implants S.A. is 24 days.
Which FDA product codes appear under Integra Neurosciences Implants S.A.?
The most frequent FDA product codes under this applicant name are JXG (Shunt, Central Nervous System And Components, 6).
Next steps
- See all 6 Integra Neurosciences Implants S.A. clearances with predicates and recalls
- Run predicate analysis for product code JXG, Integra Neurosciences Implants 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.