Icotec AG - FDA 510(k) Cleared Devices
16
Total
16
Cleared
0
Denied
Icotec AG has 16 FDA 510(k) cleared orthopedic devices. Based in Altstaetten, SE.
Latest FDA clearance: Nov 2025. Active since 2016.
Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.
Regulatory submissions have been managed by Mcra, LLC and MRCA, LLC.
16 devices
Cleared
Nov 12, 2025
CMORE® CT System
Orthopedic
110d
Cleared
Feb 27, 2025
VADER® Pedicle System and VADER®one Pedicle System
Orthopedic
157d
Cleared
May 17, 2024
icotec Anterior Cervical Plate System
Orthopedic
234d
Cleared
Apr 05, 2024
icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage,...
Orthopedic
207d
Cleared
Apr 04, 2024
KONG®-TL VBR System and KONG® C VBR System
Orthopedic
206d
Cleared
Feb 26, 2024
VADER® Pedicle System
Orthopedic
181d
Cleared
Jun 27, 2023
VADER® Pedicle System Navigated Instruments
Orthopedic
90d
Cleared
Jan 09, 2023
VADER® Pedicle System, G21 Cement
Orthopedic
116d
Cleared
Oct 15, 2020
icotec Anterior Cervical Plate System
Orthopedic
126d
Cleared
Oct 13, 2020
G21 Cement, VADER® Pedicle System
Orthopedic
221d
Cleared
May 29, 2020
KONG-TL VBR System, KONG-C VBR System
Orthopedic
120d
Cleared
May 22, 2020
VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0
Orthopedic
165d