Icotec Ag

FDA Filings

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.

FDA Registration(s)
Registration Number3006493760
FEI Number3006493760
NameICOTEC AG
Owner & Operatoricotec ag
Contact AddressIndustriestrasse 12
Altstaetten CH-SG Sankt Gallen 9450 CH
Official Correspondent
  • Valeria Consiero
  • 041-71-75700-55
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressIndustriestrasse 12
Altstaetten Sankt Gallen, 9450 CH
Establishment Type
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
icotec AG
VADER Pedicle System, K-wire, Nitinol, Ø 1.1 x 600 mm 42-542-12024-12-02
icotec AG
VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 x 600 mm 42-546-12024-12-02
icotec AG
VADER Pedicle System, K-wire Dispenser, Extra Long, Ø 1.6 x 600 mm, Ø 1.1 x 600 42-8812024-12-02
icotec AG
VADER Pedicle System Counter Torque Wrench 42-7902024-10-22
icotec AG
VADER Pedicle System, Rod inserter, for cut rods 42-8992024-09-11
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 240 mm 16-60-245242024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 220 mm 16-60-245222024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 200 mm 16-60-245202024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 180 mm 16-60-245182024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 160 mm 16-60-245162024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 140 mm 16-60-245142024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 120 mm 16-60-245122024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 100 mm 16-60-245102024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 080 mm 16-60-245082024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 120 mm 16-60-212122024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 100 mm 16-60-212102024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 090 mm 16-60-212092024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 080 mm 16-60-212082024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 070 mm 16-60-212072024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 060 mm 16-60-212062024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 050 mm 16-60-212052024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 040 mm 16-60-212042024-08-08
icotec AG
VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, L2, Ø 6.0 x 300 mm 16-60-2MC30-52024-08-08
icotec AG
VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, L1, Ø 6.0 x 300 mm 16-60-2MC30-42024-08-08
icotec AG
VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, TL1, Ø 6.0 x 300 mm 16-60-2MC30-32024-08-08
icotec AG
VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, HT2, Ø 6.0 x 300 mm 16-60-2MC30-22024-08-08
icotec AG
VADER Pedicle System, S-Rod, Carbon/PEEK, multi-curved, HT1, Ø 6.0 x 300 mm 16-60-2MC30-12024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 160 mm 16-60-200162024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 140 mm 16-60-200142024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 120 mm 16-60-200122024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 100 mm 16-60-200102024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 090 mm 16-60-200092024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 080 mm 16-60-200082024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 070 mm 16-60-200072024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 060 mm 16-60-200062024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 050 mm 16-60-200052024-08-08
icotec AG
VADER Pedicle System, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 040 mm 16-60-200042024-08-08
icotec AG
VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 50 mm 16-6022-545502024-08-08
icotec AG
VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 45 mm 16-6022-545452024-08-08
icotec AG
VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 40 mm 16-6022-545402024-08-08
icotec AG
VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 35 mm 16-6022-545352024-08-08
icotec AG
VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 30 mm 16-6022-545302024-08-08
icotec AG
VADER Pedicle System ,Screw, Carbon/PEEK, Polyax., Fen., Ø 4.5 × 25 mm 16-6022-545252024-08-08
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 7.5 x 60 mm 16-6023-575602024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 7.5 x 55 mm 16-6023-575552024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 7.5 x 50 mm 16-6023-575502024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial , Ø 7.5 x 45 mm 16-6023-575452024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 7.5 x 40 mm 16-6023-575402024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 7.5 x 35 mm 16-6023-575352024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 7.5 x 30 mm 16-6023-575302024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 60 mm 16-6023-565602024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 55 mm 16-6023-565552024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 50 mm 16-6023-565502024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 45 mm 16-6023-565452024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 40 mm 16-6023-565402024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 35 mm 16-6023-565352024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 6.5 x 30 mm 16-6023-565302024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 60 mm 16-6023-555602024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 55 mm 16-6023-555552024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 50 mm 16-6023-555502024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 45 mm 16-6023-555452024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 40 mm 16-6023-555402024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 35 mm 16-6023-555352024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 30 mm 16-6023-555302024-04-04
icotec AG
VADERone Pedicle System, Screw, Carbon/PEEK, Polyaxial, Ø 5.5 x 25 mm 16-6023-555252024-04-04
icotec AG
icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 60 mm 16-6023-985602024-04-04
icotec AG
icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 55 mm 16-6023-985552024-04-04
icotec AG
icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 50 mm 16-6023-985502024-04-04
icotec AG
icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 45 mm 16-6023-985452024-04-04
icotec AG
icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 40 mm 16-6023-985402024-04-04
icotec AG
icotec Pedicle System 6.0, Screw, Ti, Polyaxial, Ø 8.5 x 35 mm 16-6023-985352024-04-04
icotec AG
VADER Pedicle System MIS, Rod, Carbon/PEEK, Curved, Ø 6.0 r450 x 30 mm 16-60-745032024-04-04
icotec AG
VADER Pedicle System MIS, Rod, Carbon/PEEK, Curved, Ø 6.0 r120 x 30 mm 16-60-712032024-04-04
icotec AG
VADER Pedicle System MIS, Rod, Carbon/PEEK, Straight, Ø 6.0 r000 x 30 mm 16-60-700032024-04-04
icotec AG
VADER Pedicle System, Fixation device 42-8932024-03-27
icotec AG
icotec Lumbar Cage ETurn TLIF 8 x 12 mm 12-57-12-32-08-ITi2024-03-06
icotec AG
icotec Lumbar Cage PLIF 8° / 25 mm x 15 mm 12-59-825152024-03-06
icotec AG
icotec Lumbar Cage PLIF 8° / 25 mm x 13 mm 12-59-825132024-03-06
icotec AG
icotec Lumbar Cage PLIF 8° / 25 mm x 11 mm 12-59-825112024-03-06
icotec AG
icotec Lumbar Cage PLIF 8° / 25 mm x 09 mm 12-59-825092024-03-06
icotec AG
icotec Lumbar Cage PLIF 0° / 25 mm x 15 mm 12-59-025152024-03-06
icotec AG
icotec Lumbar Cage PLIF 0° / 25 mm x 13 mm 12-59-025132024-03-06
icotec AG
icotec Lumbar Cage PLIF 0° / 25 mm x 11 mm 12-59-025112024-03-06
icotec AG
icotec Lumbar Cage PLIF 0° / 25 mm x 09 mm 12-59-025092024-03-06
icotec AG
icotec Lumbar Cage PLIF 0° / 25 mm x 07 mm 12-59-025072024-03-06
icotec AG
icotec Lumbar Cage PLIF 4° / 25 mm x 15 mm 12-59-425152024-03-06
icotec AG
icotec Lumbar Cage PLIF 4° / 25 mm x 13 mm 12-59-425132024-03-06
icotec AG
icotec Lumbar Cage PLIF 4° / 25 mm x 11 mm 12-59-425112024-03-06
icotec AG
icotec Lumbar Cage PLIF 4° / 25 mm x 09 mm 12-59-425092024-03-06
icotec AG
icotec Lumbar Cage PLIF 4° / 25 mm x 07 mm 12-59-425072024-03-06
icotec AG
icotec Lumbar Cage ETurn TLIF 15 x 16 mm 12-58-16-32-15-ITi2024-03-06
icotec AG
icotec Lumbar Cage ETurn TLIF 13 x 16 mm 12-58-16-32-13-ITi2024-03-06
icotec AG
icotec Lumbar Cage ETurn TLIF 11 x 16 mm 12-58-16-32-11-ITi2024-03-06
icotec AG
icotec Lumbar Cage ETurn TLIF 09 x 16 mm 12-58-16-32-09-ITi2024-03-06
icotec AG
icotec Lumbar Cage ETurn TLIF 07 x 16 mm 12-58-16-32-07-ITi2024-03-06
icotec AG
icotec Lumbar Cage ETurn TLIF 15 x 12 mm 12-57-12-32-15-ITi2024-03-06
icotec AG
icotec Lumbar Cage ETurn TLIF 13 x 12 mm 12-57-12-32-13-ITi2024-03-06
icotec AG
icotec Lumbar Cage ETurn TLIF 11 x 12 mm 12-57-12-32-11-ITi2024-03-06
icotec AG
icotec Lumbar Cage ETurn TLIF 9 x 12 mm 12-57-12-32-09-ITi2024-03-06
icotec AG
icotec Lumbar Cage ETurn TLIF 7 x 12 mm 12-57-12-32-07-ITi2024-03-06
Icotec AG
Icotec Anterior Cervical Plate System2020-10-15
Icotec Ag
KONG-TL VBR System, KONG-C VBR System2020-05-29
Icotec AG
VADER®one Pedicle System MIS And LightMore® Pedicle System 6.02020-05-22
Icotec Ag
Icotec Cervical Cage2020-03-20
Icotec Ag
VADER® One Pedicle System MIS And LightMore® Pedicle System 6.02019-06-20
Icotec Ag
Icotec Interbody Cage System2018-05-17
ICOTEC AG
Icotec Pedicle System2016-04-12

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