Company · CH
Icotec AG
FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2025. Name variants (Inc, Corp, punctuation) are merged.
17510(k) clearances (1 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 6 |
| PML | Bone Cement, Posterior Screw Augmentation | 4 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 2 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 2 |
| MQP | Spinal Vertebral Body Replacement Device | 2 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 2 |
| NKG | Posterior Cervical Screw System | 1 |
| OLO | Orthopedic Stereotaxic Instrument | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 12, 2025 | K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments Icotec AG, CH | NKG |
| Feb 27, 2025 | K242900 | VADER® Pedicle System and VADER®one Pedicle System Icotec AG, CH | NKB |
| May 17, 2024 | K233215 | icotec Anterior Cervical Plate System Icotec AG, CH | KWQ |
| Apr 5, 2024 | K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage) Icotec AG, CH | MAX |
| Apr 4, 2024 | K232790 | KONG®-TL VBR System and KONG® C VBR System Icotec AG, CH | MQP |
| Feb 26, 2024 | K232628 | VADER® Pedicle System Icotec AG, CH | NKB |
| Jun 27, 2023 | K230861 | VADER® Pedicle System Navigated Instruments Icotec AG, CH | OLO |
| Jan 9, 2023 | K222789 | VADER® Pedicle System, G21 Cement Icotec AG, CH | PML |
| Oct 15, 2020 | K201587 | icotec Anterior Cervical Plate System Icotec AG, CH | KWQ |
| Oct 13, 2020 | K200596 | G21 Cement, VADER® Pedicle System Icotec AG, CH | PML |
| May 29, 2020 | K200235 | KONG-TL VBR System, KONG-C VBR System Icotec AG, CH | MQP |
| May 22, 2020 | K193423 | VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 Icotec AG, CH | NKB |
| Mar 20, 2020 | K192897 | icotec Cervical Cage Icotec AG, CH | ODP |
| Jun 20, 2019 | K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 Icotec AG, CH | NKB |
| May 17, 2018 | K172480 | icotec Interbody Cage System Icotec AG, CH | ODP |
| Apr 12, 2016 | K151977 | icotec Pedicle System Icotec AG, SE | NKB |
| Jul 21, 2011 | K100305 | ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 K; ETURN XX-16 K WHER Icotec | MAX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2024 | Icotec Ag VADER pedicle system, torque wrench, Catalog Number 42-703 Open, Classified |
PML | K222789 |
| Jan 10, 2024 | Icotec Ag VADER pedicle system, torque wrench, Catalog Number 42-702 Open, Classified |
PML | K222789 |
| Dec 19, 2022 | Icotec Ag VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 Terminated |
NKB | K190545 K193423 +1 |