Icotec Ag

FDA Regulatory Profile

Summary

Total Recalls
3
510(k) Clearances
17
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-0700-2024Class IIVADER pedicle system, torque wrench, Catalog Number 42-702November 28, 2023
Z-0701-2024Class IIVADER pedicle system, torque wrench, Catalog Number 42-703November 28, 2023
Z-0728-2023Class IIVADER Pedicle System Torque Wrench, Hudson Coupling, 12 Nm, REF 42-702November 3, 2022

Recent 510(k) Clearances

K-NumberDeviceDate
K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsNovember 12, 2025
K242900VADER® Pedicle System and VADER®one Pedicle SystemFebruary 27, 2025
K233215icotec Anterior Cervical Plate SystemMay 17, 2024
K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF LumbApril 5, 2024
K232790KONG®-TL VBR System and KONG® C VBR SystemApril 4, 2024
K232628VADER® Pedicle SystemFebruary 26, 2024
K230861VADER® Pedicle System Navigated InstrumentsJune 27, 2023
K222789VADER® Pedicle System, G21 CementJanuary 9, 2023
K201587icotec Anterior Cervical Plate SystemOctober 15, 2020
K200596G21 Cement, VADER® Pedicle SystemOctober 13, 2020
K200235KONG-TL VBR System, KONG-C VBR SystemMay 29, 2020
K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0May 22, 2020
K192897icotec Cervical CageMarch 20, 2020
K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0June 20, 2019
K172480icotec Interbody Cage SystemMay 17, 2018
K151977icotec Pedicle SystemApril 12, 2016
K100305ETURN SPINAL IMPLANT MODEL ETURN XX-12; ETURN XX-16 WHERE XX=07, 09, 11, 13, OR 15 AND ETURN XX-12 KJuly 21, 2011