This page includes the latest FDA filings for Icotec Ag. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3006493760 |
| FEI Number | 3006493760 |
| Name | ICOTEC AG |
| Owner & Operator | icotec ag |
| Contact Address | Industriestrasse 12 Altstaetten CH-SG Sankt Gallen 9450 CH |
| Official Correspondent |
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| US Agent |
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| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | Industriestrasse 12 Altstaetten Sankt Gallen, 9450 CH |
| Establishment Type |
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Device Company | Device | Date |
|---|---|---|
| icotec AG | VADER Pedicle System K-wire Dispenser, long For K-wire 1.6 x 472 mm, 1.1 x 472 m 42-880 | 2025-06-03 |
| icotec AG | VADER Pedicle System, Torque Wrench for Connectors, T15, 3.5 Nm 42-597 | 2025-03-13 |
| icotec AG | VADER Pedicle System, Screwdriver for Connectors, T15, 3.5 Nm 42-596 | 2025-03-13 |
| icotec AG | icotec Systems, Torque-Limiting Adapter, 3.5 Nm 60-035 | 2025-03-13 |
| icotec AG | VADER Pedicle System, Parallel Connector, Closed, Ø 6.0 mm - Ø 6.0 mm 16-6060-0225 | 2025-03-13 |
| icotec AG | VADER Pedicle System, Axial Connector, Ø 6.0 mm - Ø 6.0 mm 16-6060-0126 | 2025-03-13 |
| icotec AG | VADER Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm 42-542-1 | 2024-12-02 |
| icotec AG | VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 x 600 mm 42-546-1 | 2024-12-02 |
| icotec AG | VADER Pedicle System, K-wire Dispenser, Extra Long, Ø 1.6 x 600 mm, Ø 1.1 x 600 42-881 | 2024-12-02 |
| icotec AG | VADER Pedicle System Counter Torque Wrench 42-790 | 2024-10-22 |
| icotec AG | VADER Pedicle System, Rod inserter, for cut rods 42-899 | 2024-09-11 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 240 mm 16-60-24524 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 220 mm 16-60-24522 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 200 mm 16-60-24520 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 180 mm 16-60-24518 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 160 mm 16-60-24516 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 140 mm 16-60-24514 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 120 mm 16-60-24512 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 100 mm 16-60-24510 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 080 mm 16-60-24508 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 120 mm 16-60-21212 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 100 mm 16-60-21210 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 090 mm 16-60-21209 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 080 mm 16-60-21208 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 070 mm 16-60-21207 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 060 mm 16-60-21206 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 050 mm 16-60-21205 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 040 mm 16-60-21204 | 2024-08-08 |
| icotec AG | VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, L2, Ø 6.0 x 300 mm 16-60-2MC30-5 | 2024-08-08 |
| icotec AG | VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, L1, Ø 6.0 x 300 mm 16-60-2MC30-4 | 2024-08-08 |
| icotec AG | VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, TL1, Ø 6.0 x 300 mm 16-60-2MC30-3 | 2024-08-08 |
| icotec AG | VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, HT2, Ø 6.0 x 300 mm 16-60-2MC30-2 | 2024-08-08 |
| icotec AG | VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, HT1, Ø 6.0 x 300 mm 16-60-2MC30-1 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 160 mm 16-60-20016 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 140 mm 16-60-20014 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 120 mm 16-60-20012 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 100 mm 16-60-20010 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 090 mm 16-60-20009 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 080 mm 16-60-20008 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 070 mm 16-60-20007 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 060 mm 16-60-20006 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 050 mm 16-60-20005 | 2024-08-08 |
| icotec AG | VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 040 mm 16-60-20004 | 2024-08-08 |
| icotec AG | VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 50 mm 16-6022-54550 | 2024-08-08 |
| icotec AG | VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 45 mm 16-6022-54545 | 2024-08-08 |
| icotec AG | VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 40 mm 16-6022-54540 | 2024-08-08 |
| icotec AG | VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 35 mm 16-6022-54535 | 2024-08-08 |
| icotec AG | VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 30 mm 16-6022-54530 | 2024-08-08 |
| icotec AG | VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 25 mm 16-6022-54525 | 2024-08-08 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 7.5 x 60 mm 16-6023-57560 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 7.5 x 55 mm 16-6023-57555 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 7.5 x 50 mm 16-6023-57550 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial , Ø 7.5 x 45 mm 16-6023-57545 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 7.5 x 40 mm 16-6023-57540 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 7.5 x 35 mm 16-6023-57535 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 7.5 x 30 mm 16-6023-57530 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 60 mm 16-6023-56560 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 55 mm 16-6023-56555 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 50 mm 16-6023-56550 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 45 mm 16-6023-56545 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 40 mm 16-6023-56540 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 35 mm 16-6023-56535 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 30 mm 16-6023-56530 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 60 mm 16-6023-55560 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 55 mm 16-6023-55555 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 50 mm 16-6023-55550 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 45 mm 16-6023-55545 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 40 mm 16-6023-55540 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 35 mm 16-6023-55535 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 30 mm 16-6023-55530 | 2024-04-04 |
| icotec AG | VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 25 mm 16-6023-55525 | 2024-04-04 |
| icotec AG | icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 60 mm 16-6023-98560 | 2024-04-04 |
| icotec AG | icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 55 mm 16-6023-98555 | 2024-04-04 |
| icotec AG | icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 50 mm 16-6023-98550 | 2024-04-04 |
| icotec AG | icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 45 mm 16-6023-98545 | 2024-04-04 |
| icotec AG | icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 40 mm 16-6023-98540 | 2024-04-04 |
| icotec AG | icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 35 mm 16-6023-98535 | 2024-04-04 |
| icotec AG | VADER Pedicle System MIS, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 30 mm 16-60-74503 | 2024-04-04 |
| icotec AG | VADER Pedicle System MIS, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 30 mm 16-60-71203 | 2024-04-04 |
| icotec AG | VADER Pedicle System MIS, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 30 mm 16-60-70003 | 2024-04-04 |
| icotec AG | VADER Pedicle System, Fixation device 42-893 | 2024-03-27 |
| icotec AG | icotec Lumbar Cage PLIF 0° / 25 mm x 13 mm 12-59-02513 | 2024-03-06 |
| icotec AG | icotec Lumbar Cage PLIF 0° / 25 mm x 11 mm 12-59-02511 | 2024-03-06 |
| icotec AG | icotec Lumbar Cage PLIF 0° / 25 mm x 09 mm 12-59-02509 | 2024-03-06 |
| icotec AG | icotec Lumbar Cage PLIF 0° / 25 mm x 07 mm 12-59-02507 | 2024-03-06 |
| icotec AG | icotec Lumbar Cage PLIF 4° / 25 mm x 15 mm 12-59-42515 | 2024-03-06 |
| icotec AG | icotec Lumbar Cage PLIF 4° / 25 mm x 13 mm 12-59-42513 | 2024-03-06 |
| icotec AG | icotec Lumbar Cage PLIF 4° / 25 mm x 11 mm 12-59-42511 | 2024-03-06 |
| icotec AG | icotec Lumbar Cage PLIF 4° / 25 mm x 09 mm 12-59-42509 | 2024-03-06 |
| icotec AG | icotec Lumbar Cage PLIF 4° / 25 mm x 07 mm 12-59-42507 | 2024-03-06 |
| icotec AG | icotec Lumbar Cage ETurn TLIF 15 x 16 mm 12-58-16-32-15-ITi | 2024-03-06 |
| icotec AG | icotec Lumbar Cage ETurn TLIF 13 x 16 mm 12-58-16-32-13-ITi | 2024-03-06 |
| icotec AG | icotec Lumbar Cage ETurn TLIF 11 x 16 mm 12-58-16-32-11-ITi | 2024-03-06 |
| icotec AG | icotec Lumbar Cage ETurn TLIF 09 x 16 mm 12-58-16-32-09-ITi | 2024-03-06 |
| icotec AG | icotec Lumbar Cage ETurn TLIF 07 x 16 mm 12-58-16-32-07-ITi | 2024-03-06 |
| icotec AG | icotec Lumbar Cage ETurn TLIF 15 x 12 mm 12-57-12-32-15-ITi | 2024-03-06 |
| icotec AG | icotec Lumbar Cage ETurn TLIF 13 x 12 mm 12-57-12-32-13-ITi | 2024-03-06 |
| icotec AG | icotec Lumbar Cage ETurn TLIF 11 x 12 mm 12-57-12-32-11-ITi | 2024-03-06 |
| icotec AG | icotec Lumbar Cage ETurn TLIF 9 x 12 mm 12-57-12-32-09-ITi | 2024-03-06 |
| icotec AG | icotec Lumbar Cage ETurn TLIF 7 x 12 mm 12-57-12-32-07-ITi | 2024-03-06 |
Icotec AG | Icotec Anterior Cervical Plate System | 2020-10-15 |
Icotec Ag | KONG-TL VBR System, KONG-C VBR System | 2020-05-29 |
Icotec AG | VADER®one Pedicle System MIS And LightMore® Pedicle System 6.0 | 2020-05-22 |
Icotec Ag | Icotec Cervical Cage | 2020-03-20 |
Icotec Ag | VADER® One Pedicle System MIS And LightMore® Pedicle System 6.0 | 2019-06-20 |
Icotec Ag | Icotec Interbody Cage System | 2018-05-17 |
ICOTEC AG | Icotec Pedicle System | 2016-04-12 |