Company ยท FR
Implanet, S.A.
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2026. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| OWI | Bone Fixation Cerclage, Sublaminar | 7 |
| NKB | Thoracolumbosacral Pedicle Screw System | 6 |
| JDQ | Cerclage, Fixation | 1 |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 26, 2026 | K254017 | SWINGO-3D Lumbar Cage System Implanet, FR | MAX |
| Aug 28, 2025 | K252437 | JAZZ Spinal System Implanet, FR | NKB |
| May 6, 2024 | K240392 | JAZZ Spinal System Implanet, FR | NKB |
| Mar 28, 2023 | K230026 | SQUALE Implanet, S.A., FR | ODP |
| Oct 22, 2019 | K192084 | Madison Total Knee System Implanet, S.A., FR | JWH |
| Aug 2, 2019 | K191217 | JAZZ PF Implanet, S.A., FR | OWI |
| Mar 12, 2019 | K182771 | ISS-JAZZ Screw System and JAZZ CAP SP Implanet, S.A., FR | NKB |
| Aug 8, 2017 | K171881 | JAZZ Passer Band Implanet, S.A., FR | OWI |
| Jun 9, 2017 | K170730 | JAZZ System, including JAZZ Band Implanet, S.A., FR | OWI |
| Jan 19, 2017 | K162764 | JAZZ FRAME SYSTEM Implanet, S.A., FR | NKB |
| May 18, 2016 | K160226 | JAZZ CLAW System (hooks and rods) and JAZZ CLAW connector Implanet, S.A., FR | NKB |
| Mar 31, 2016 | K153348 | JAZZ LOCK Implanet, S.A., FR | OWI |
| Aug 27, 2015 | K151740 | JAZZ System Implanet, S.A., FR | OWI |
| May 7, 2015 | K143759 | JAZZ System Implanet, S.A., FR | OWI |
| Apr 14, 2015 | K143731 | IMPLANET Spine System (ISS) Implanet, S.A., FR | NKB |
| Feb 20, 2014 | K133617 | JAZZ SYSTEM Implanet, S.A. | OWI |
| Oct 10, 2013 | K132303 | IMPLANET SPINE SYSTEM Implanet, S.A. | OSH |
| Sep 13, 2012 | K121541 | JAZZ SYSTEM Implanet, S.A. | JDQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||