Implanet, S.A.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Implanet, S.A.” (first 2012, latest 2023), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 92 days. Since 2017 the median was 88 days, against 85 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 |
|---|---|---|
| 2012 | 1 | 112 |
| 2013 | 1 | 78 |
| 2014 | 1 | 87 |
| 2015 | 3 | 106 |
| 2016 | 2 | 121 |
| 2017 | 3 | 92 |
| 2018 | 0 | — |
| 2019 | 3 | 88 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 83 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Implanet, S.A. took a median 88 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 85 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OWI | Bone Fixation Cerclage, Sublaminar | 7 | 7 |
| NKB | Thoracolumbosacral Pedicle Screw System | 4 | 4 |
| JDQ | Cerclage, Fixation | 1 | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 | 1 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | 1 | 1 |
Review panels
- Orthopedic (15)
Most recent Implanet, S.A. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230026 | SQUALE | ODP | 2023-03-28 | 83 |
| K192084 | Madison Total Knee System | JWH | 2019-10-22 | 81 |
| K191217 | JAZZ PF | OWI | 2019-08-02 | 88 |
| K182771 | ISS-JAZZ Screw System and JAZZ CAP SP | NKB | 2019-03-12 | 165 |
| K171881 | JAZZ Passer Band | OWI | 2017-08-08 | 46 |
| K170730 | JAZZ System, including JAZZ Band | OWI | 2017-06-09 | 92 |
| K162764 | JAZZ FRAME SYSTEM | NKB | 2017-01-19 | 111 |
| K160226 | JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector | NKB | 2016-05-18 | 110 |
| K153348 | JAZZ LOCK | OWI | 2016-03-31 | 132 |
| K151740 | JAZZ System | OWI | 2015-08-27 | 62 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Implanet, 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.
- Implanet (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Implanet, S.A.?
FDA lists 15 510(k) clearances under the applicant name “Implanet, S.A.” (first 2012, latest 2023), across 6 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 Implanet, S.A.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Implanet, S.A. is 92 days. Since 2017: 88 days, versus 85 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Implanet, S.A.?
The most frequent FDA product codes under this applicant name are OWI (Bone Fixation Cerclage, Sublaminar, 7); NKB (Thoracolumbosacral Pedicle Screw System, 4); JDQ (Cerclage, Fixation, 1).
Next steps
- See all 15 Implanet, S.A. clearances with predicates and recalls
- Run predicate analysis for product code OWI, Implanet, 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.