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Data / Medical devices / Switzerland / Icotec AG

Icotec AG: FDA-registered device maker in Altstaetten Sankt Gallen, Switzerland, 15 510(k) clearances

Icotec AG is registered with the FDA (registration 3006493760) in Altstaetten Sankt Gallen, Switzerland. It lists 10 device types. The FDA files 15 510(k) clearances under its listings, the newest dated November 12, 2025. 2 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Icotec AG
FDA registration number
3006493760
Address
Industriestrasse 12, Altstaetten Sankt Gallen, Switzerland, 9450
Owner or operator
icotec ag (10042564)
Roles
Complaint file establishment, Manufacturer
First device listed
June 15, 2018
Registered through
2026

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Complaint file establishment, Manufactureraccessdata.fda.gov
Bone Cement, Posterior Screw AugmentationPML2Complaint file establishment, Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Complaint file establishment, Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Complaint file establishment, Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Complaint file establishment, Manufactureraccessdata.fda.gov
Posterior Cervical Screw SystemNKG2Complaint file establishment, Manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement DeviceMQP2Complaint file establishment, Manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement Device - CervicalPLR2Complaint file establishment, Manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Complaint file establishment, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
November 12, 2025K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsNKGSubstantially EquivalentIcotec AGaccessdata.fda.gov
February 27, 2025K242900VADER® Pedicle System and VADER®one Pedicle SystemNKBSubstantially EquivalentIcotec AGaccessdata.fda.gov
May 17, 2024K233215icotec Anterior Cervical Plate SystemKWQSubstantially EquivalentIcotec AGaccessdata.fda.gov
April 5, 2024K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)MAXSubstantially EquivalentIcotec AGaccessdata.fda.gov
April 4, 2024K232790KONG®-TL VBR System and KONG® C VBR SystemMQPSubstantially EquivalentIcotec AGaccessdata.fda.gov
February 26, 2024K232628VADER® Pedicle SystemNKBSubstantially EquivalentIcotec AGaccessdata.fda.gov
June 27, 2023K230861VADER® Pedicle System Navigated InstrumentsOLOSubstantially EquivalentIcotec AGaccessdata.fda.gov
January 9, 2023K222789VADER® Pedicle System, G21 CementPMLSubstantially EquivalentIcotec AGaccessdata.fda.gov
October 15, 2020K201587icotec Anterior Cervical Plate SystemKWQSubstantially EquivalentIcotec AGaccessdata.fda.gov
October 13, 2020K200596G21 Cement, VADER® Pedicle SystemPMLSubstantially EquivalentIcotec AGaccessdata.fda.gov
May 29, 2020K200235KONG-TL VBR System, KONG-C VBR SystemMQPSubstantially EquivalentIcotec AGaccessdata.fda.gov
May 22, 2020K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0NKBSubstantially EquivalentIcotec AGaccessdata.fda.gov
March 20, 2020K192897icotec Cervical CageODPSubstantially EquivalentIcotec AGaccessdata.fda.gov
June 20, 2019K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0NKBSubstantially EquivalentIcotec AGaccessdata.fda.gov
May 17, 2018K172480icotec Interbody Cage SystemODPSubstantially EquivalentIcotec AGaccessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

InitiatedEventClassStatusProductReasonSource
November 28, 202393577Class IIOngoingVADER pedicle system, torque wrench, Catalog Number 42-702icotec 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 accessdata.fda.gov
November 3, 202291174Class IITerminatedVADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702During 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.accessdata.fda.gov

Compare with other makers

Updated November 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.