Icotec AG
Altstaetten Sankt Gallen, CH
ICOTEC AG appears in FDA device records in Altstaetten Sankt Gallen, CH. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Icotec AG between 2011 and 2025. The busiest year on record is 2020, with 5. The most recent is 2025, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2011 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 5 |
| 2023 | 2 |
| 2024 | 4 |
| 2025 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252327 | CMORE® CT System; CMORE® CT System Navigated Instruments | NKG | Substantially Equivalent | |
| K242900 | VADER® Pedicle System and VADER®one Pedicle System | NKB | Substantially Equivalent | |
| K233215 | icotec Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage) | MAX | Substantially Equivalent | |
| K232790 | KONG®-TL VBR System and KONG® C VBR System | MQP | Substantially Equivalent | |
| K232628 | VADER® Pedicle System | NKB | Substantially Equivalent | |
| K230861 | VADER® Pedicle System Navigated Instruments | OLO | Substantially Equivalent | |
| K222789 | VADER® Pedicle System, G21 Cement | PML | Substantially Equivalent | |
| K201587 | icotec Anterior Cervical Plate System | KWQ | Substantially Equivalent | |
| K200596 | G21 Cement, VADER® Pedicle System | PML | Substantially Equivalent | |
| K200235 | KONG-TL VBR System, KONG-C VBR System | MQP | Substantially Equivalent | |
| K193423 | VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0 | NKB | Substantially Equivalent | |
| K192897 | icotec Cervical Cage | ODP | Substantially Equivalent | |
| K190545 | VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0 | NKB | Substantially Equivalent | |
| K172480 | icotec Interbody Cage System | ODP | Substantially Equivalent | |
| K151977 | icotec Pedicle System | NKB | Substantially Equivalent | |
| 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 | MAX | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006493760 | 3006493760 | ICOTEC AG | Industriestrasse 12, Altstaetten Sankt Gallen 9450 CH | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KWQAppliance, Fixation, Spinal Intervertebral Body
- PMLBone Cement, Posterior Screw Augmentation
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- LXHOrthopedic Manual Surgical Instrument
- OLOOrthopedic Stereotaxic Instrument
- NKGPosterior Cervical Screw System
- MQPSpinal Vertebral Body Replacement Device
- PLRSpinal Vertebral Body Replacement Device - Cervical
- NKBThoracolumbosacral Pedicle Screw System
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0701-2024 | VADER pedicle system, torque wrench, Catalog Number 42-703 | icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently. | Class II | Open, Classified | |
| Z-0700-2024 | VADER pedicle system, torque wrench, Catalog Number 42-702 | icotec has received notification of one revision that had to be carried out because nut screws had become loose. During the investigation of the device involved, it was detected that the torque limiting function of the wrench used to tighten the nut screws during implantation was not functioning correctly. Due to the malfunction, the nut screws may not have been tightened sufficiently. | Class II | Open, Classified | |
| Z-0728-2023 | VADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702 | During internal testing (at manufacturer site) of two torque wrench devices, it was detected that the torque limiting function was out of specification. The specified torque limiting value is 12 Nm. The measuring results for both instruments were 4 Nm. | Class II | Open, Classified |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain