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Icotec AG

FDA 510(k) & PMA Approved Devices — 16 products

Total Devices16
Categories8
Latest FDA decision2025-11-12
TypeNumberDevice NameCodeDateActions
510(k) K252327 CMORE® CT System; CMORE® CT System Navigated InstrumentsNKG2025-11-12 View
510(k) K242900 VADER® Pedicle System and VADER®one Pedicle SystemNKB2025-02-27 View
510(k) K233215 icotec Anterior Cervical Plate SystemKWQ2024-05-17 View
510(k) K232792 icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)MAX2024-04-05 View
510(k) K232790 KONG®-TL VBR System and KONG® C VBR SystemMQP2024-04-04 View
510(k) K232628 VADER® Pedicle SystemNKB2024-02-26 View
510(k) K230861 VADER® Pedicle System Navigated InstrumentsOLO2023-06-27 View
510(k) K222789 VADER® Pedicle System, G21 CementPML2023-01-09 View
510(k) K201587 icotec Anterior Cervical Plate SystemKWQ2020-10-15 View
510(k) K200596 G21 Cement, VADER® Pedicle SystemPML2020-10-13 View
510(k) K200235 KONG-TL VBR System, KONG-C VBR SystemMQP2020-05-29 View
510(k) K193423 VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0NKB2020-05-22 View
510(k) K192897 icotec Cervical CageODP2020-03-20 View
510(k) K190545 VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0NKB2019-06-20 View
510(k) K172480 icotec Interbody Cage SystemODP2018-05-17 View
510(k) K151977 icotec Pedicle SystemNKB2016-04-12 View
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