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
CMORE® System, Torque Wrench, Integrated, AO-Coupling, 3.5 Nm 45-4002025-12-02
icotec AG
CMORE® System, Nut Screw Final Driver, Hex 4.0 mm 45-3902025-12-02
icotec AG
CMORE® System, Locking Counter Torque 45-3802025-12-02
icotec AG
CMORE® System, Persuader 45-3202025-12-02
icotec AG
CMORE® System, Flexible Trial Rod, with Nitinol Wire , Ø 3.5 mm; L = 300 mm 45-230-22025-12-02
icotec AG
CMORE® System, Flexible Trial Rod, with Stainless Steel Wire, Ø 3.5 mm; L = 300 45-230-12025-12-02
icotec AG
CMORE® System, Navigated Screwdriver, with Magnetic Plate, T15 45-200N-22025-12-02
icotec AG
CMORE® System, Screwdriver, Simple, T15 45-200-12025-12-02
icotec AG
CMORE® System, Navigated Screwdriver, Simple, T15 45-200N-12025-12-02
icotec AG
CMORE® System, CMORE® CT System Navigated Instruments, Container Base 45-870-12025-12-02
icotec AG
CMORE® System, Tap Sleeve 45-1602025-12-02
icotec AG
CMORE® System, Drill Guide Stop Navigated 45-030N-12025-12-02
icotec AG
CMORE® System, Navigated Awl 45-010N2025-12-02
icotec AG
CMORE® System, Screwdriver for Connectors, T15 45-6002025-12-02
icotec AG
CMORE® System, Parallel Connector, Closed, Ø 4.0 mm - Ø 6.0 mm 16-4060-03232025-12-02
icotec AG
CMORE® System, Axial Connector, Ø 4.0 mm - Ø 6.0 mm 16-4060-01242025-12-02
icotec AG
CMORE® System, Nut Screw, Ti 16-40-910002025-12-02
icotec AG
CMORE® System, S-Rod, Carbon/PEEK, Multi Curved, CT2 , Ø 4.0 - 200 mm 16-40-1MC20-22025-12-02
icotec AG
CMORE® System, S-Rod, Carbon/PEEK, Multi Curved, CT1, Ø 4.0 - 200 mm 16-40-1MC20-12025-12-02
icotec AG
CMORE® System, Rod, Carbon/PEEK, Curved, Ø 4.0 r120 - 100 mm 16-40-112102025-12-02
icotec AG
CMORE® System, Rod, Carbon/PEEK, Curved, Ø 4.0 r120 - 90 mm 16-40-112092025-12-02
icotec AG
CMORE® System, Rod, Carbon/PEEK, Curved, Ø 4.0 r120 - 80 mm 16-40-112082025-12-02
icotec AG
CMORE® System, Rod, Carbon/PEEK, Curved, Ø 4.0 r120 - 70 mm 16-40-112072025-12-02
icotec AG
CMORE® System, Rod, Carbon/PEEK, Curved, Ø 4.0 r120 - 60 mm 16-40-112062025-12-02
icotec AG
CMORE® System, Rod, Carbon/PEEK, Curved, Ø 4.0 r120 - 50 mm 16-40-112052025-12-02
icotec AG
CMORE® System, Rod, Carbon/PEEK, Curved, Ø 4.0 r120 - 40 mm 16-40-112042025-12-02
icotec AG
CMORE® System, Rod, Carbon/PEEK, Curved, Ø 4.0 r120 - 30 mm 16-40-112032025-12-02
icotec AG
CMORE® System, Rod, Carbon/PEEK, Straight , Ø 4.0 r000 - 60 mm 16-40-100062025-12-02
icotec AG
CMORE® System, Rod, Carbon/PEEK, Straight , Ø 4.0 r000 - 50 mm 16-40-100052025-12-02
icotec AG
CMORE® System, Rod, Carbon/PEEK, Straight , Ø 4.0 r000 - 40 mm 16-40-100042025-12-02
icotec AG
CMORE® System, Rod, Carbon/PEEK, Straight , Ø 4.0 r000 - 30 mm 16-40-100032025-12-02
icotec AG
CMORE® System, Rod, Ti, Straight, Ø 4.0 r000 - 300 mm 16-40-900302025-12-02
icotec AG
CMORE® System, Shank Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 34 mm 16-4025-340342025-12-02
icotec AG
CMORE® System, Shank Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 32 mm 16-4025-340322025-12-02
icotec AG
CMORE® System, Shank Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 30 mm 16-4025-340302025-12-02
icotec AG
CMORE® System, Shank Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 28 mm 16-4025-340282025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 5.0 × 45 mm 16-4020-350452025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 5.0 × 40 mm 16-4020-350402025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 5.0 × 35 mm 16-4020-350352025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 5.0 × 30 mm 16-4020-350302025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 5.0 × 25 mm 16-4020-350252025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 40 mm 16-4020-345402025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 38 mm 16-4020-345382025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 36 mm 16-4020-345362025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 34 mm 16-4020-345342025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 32 mm 16-4020-345322025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 30 mm 16-4020-345302025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 28 mm 16-4020-345282025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 26 mm 16-4020-345262025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 24 mm 16-4020-345242025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 22 mm 16-4020-345222025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 20 mm 16-4020-345202025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 18 mm 16-4020-345182025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 16 mm 16-4020-345162025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 14 mm 16-4020-345142025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 12 mm 16-4020-345122025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.5 × 10 mm 16-4020-345102025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 40 mm 16-4020-340402025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 38 mm 16-4020-340382025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 36 mm 16-4020-340362025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 34 mm 16-4020-340342025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 32 mm 16-4020-340322025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 30 mm 16-4020-340302025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 28 mm 16-4020-340282025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 26 mm 16-4020-340262025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 24 mm 16-4020-340242025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 22 mm 16-4020-340222025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 20 mm 16-4020-340202025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 18 mm 16-4020-340182025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 16 mm 16-4020-340162025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 14 mm 16-4020-340142025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 12 mm 16-4020-340122025-12-02
icotec AG
CMORE® System, Screw, Carbon/PEEK, Polyaxial, Solid, Ø 4.0 × 10 mm 16-4020-340102025-12-02
icotec AG
CMORE® System, Rod Pusher 45-3102025-12-02
icotec AG
CMORE® System, Nut Screw Inserter, Hex 4.0 mm 45-3002025-12-02
icotec AG
CMORE® System, Forceps 45-2902025-12-02
icotec AG
CMORE® System, Revision Sleeve 45-4402025-12-02
icotec AG
CMORE® System, Navigated Solid Tap, Ø 5.0 mm 45-150N2025-12-02
icotec AG
CMORE® System, Navigated Solid Tap, Ø 4.5 mm 45-145N2025-12-02
icotec AG
CMORE® System, Navigated Solid Tap, Ø 4.0 mm 45-140N2025-12-02
icotec AG
CMORE® System, Navigated Drill Bit, Ø 2.3 mm 45-040N2025-12-02
icotec AG
CMORE® System, Solid Tap, Ø 5.0 mm 45-1502025-12-02
icotec AG
CMORE® System, Distractor 45-3602025-12-02
icotec AG
CMORE® System, Compressor 45-3402025-12-02
icotec AG
CMORE® System, Rod Gripper 45-2802025-12-02
icotec AG
CMORE® System, French Rod Bender 45-2602025-12-02
icotec AG
CMORE® System, Rod Cutter 45-2502025-12-02
icotec AG
CMORE® System, Template for Rods CT1, CT2, R120 45-2402025-12-02
icotec AG
CMORE® System, Tulip Aligner 45-2202025-12-02
icotec AG
CMORE® System, Screwdriver Shaft, T15 45-2102025-12-02
icotec AG
CMORE® System, Solid Tap, Ø 4.5 mm 45-1452025-12-02
icotec AG
CMORE® System, Solid Tap, Ø 4.0 mm 45-1402025-12-02
icotec AG
CMORE® System, Palm Handle, AO Coupling 45-1102025-12-02
icotec AG
CMORE® System, In-line Handle, AO Coupling 45-1002025-12-02
icotec AG
CMORE® System, Feeler 45-0702025-12-02
icotec AG
CMORE® System, Drill Bit, Ø 2.3 mm 45-0402025-12-02
icotec AG
CMORE® System, Drill Guide Stop 45-030-12025-12-02
icotec AG
CMORE® System, Drill Guide Sleeve 45-0302025-12-02
icotec AG
CMORE® System, Pedicle Probe, Straight 45-0202025-12-02
icotec AG
CMORE® System, Awl 45-0102025-12-02
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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