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, Fixation device 42-8932024-03-27
icotec AG
icotec Lumbar Cage ETurn TLIF 14 x 16 mm 12-58-16-32-14-ITi2024-03-06
icotec AG
icotec Lumbar Cage ETurn TLIF 12 x 16 mm 12-58-16-32-12-ITi2024-03-06
icotec AG
icotec Lumbar Cage ETurn TLIF 10 x 16 mm 12-58-16-32-10-ITi2024-03-06
icotec AG
icotec Lumbar Cage ETurn TLIF 08 x 16 mm 12-58-16-32-08-ITi2024-03-06
icotec AG
icotec Lumbar Cage ETurn TLIF 14 x 12 mm 12-57-12-32-14-ITi2024-03-06
icotec AG
icotec Lumbar Cage ETurn TLIF 12 x 12 mm 12-57-12-32-12-ITi2024-03-06
icotec AG
icotec Lumbar Cage ETurn TLIF 10 x 12 mm 12-57-12-32-10-ITi2024-03-06
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
VADER Pedicle System, K-wire, threaded, Nitinol, Ø 1.6 × 472 mm 42-5462024-02-19
icotec AG
VADER Pedicle System, K-wire, Nitinol, Ø 1.1 × 472 mm 42-5422024-02-19
icotec AG
VADER Pedicle System, K-wire, Ø 1.1 × 472 mm 42-5412024-02-19
icotec AG
icotec Cervical Cage Anatomic 8 x 18 mm 12-41-08182024-02-07
icotec AG
icotec Cervical Cage Anatomic 7 x 18 mm 12-41-07182024-02-07
icotec AG
icotec Cervical Cage Anatomic 6 x 18 mm 12-41-06182024-02-07
icotec AG
icotec Cervical Cage Anatomic 5 x 18 mm 12-41-05182024-02-07
icotec AG
icotec Cervical Cage Anatomic 8 x 16 mm 12-41-08162024-02-07
icotec AG
icotec Cervical Cage Anatomic 7 x 16 mm 12-41-07162024-02-07
icotec AG
icotec Cervical Cage Anatomic 6 x 16 mm 12-41-06162024-02-07
icotec AG
icotec Cervical Cage Anatomic 5 x 16 mm 12-41-05162024-02-07
icotec AG
icotec Cervical Cage Anatomic 7 x 13 mm 12-41-07132024-02-07
icotec AG
icotec Cervical Cage Anatomic 6 x 13 mm 12-41-06132024-02-07
icotec AG
icotec Cervical Cage Anatomic 5 x 13 mm 12-41-05132024-02-07
icotec AG
VADER Pedicle System, VADER Pedicle System Rod-2-size, Container, complete 42-8902023-09-18
icotec AG
KONG-TL VBR System, KONG-TL VBR E, Container, complete 44-0902023-09-18
icotec AG
VADER Pedicle System MIS-2-open, Container, complete 42-8702023-09-18
icotec AG
VADER Pedicle System, VADER Pedicle System Cement Sleeve MIS, Container, complet 42-7302023-09-18
icotec AG
KONG-C VBR System, KONG-C VBR M, Container, complete 43-0902023-09-18
icotec AG
KONG-TL VBR System, KONG-TL VBR E, Container, complete 44-0802023-09-18
icotec AG
VADER Pedicle System Cement Sleeve S Container, complete 42-9302023-09-18
icotec AG
VADER Pedicle System, VADER Pedicle System Cement Sleeve, Container, complete 42-4302023-09-18
icotec AG
icotec Anterior Cervical Plate System, Cervical Plate, Container, complete 39-112023-09-18
icotec AG
VADER Pedicle System, Navigation Adapter 42-680N2023-08-18
icotec AG
VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container Inla 42-700-32023-08-16
icotec AG
VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container Lid 42-700-22023-08-16
icotec AG
VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container Base 42-700-12023-08-16
icotec AG
VADER Pedicle System, VADER Pedicle System Navigated Instruments, Container, com 42-7002023-08-16
icotec AG
VADER Pedicle System, Dilator Navigated, Ø 20.5 mm 42-649N2023-08-16
icotec AG
VADER Pedicle System, Dilator Navigated, Ø 18.5 mm 42-648N2023-08-16
icotec AG
VADER Pedicle System, Dilator Navigated, Ø 13.0 mm 42-647N2023-08-16
icotec AG
VADER Pedicle System, Navigated Cannulated Tap, Ø 7.5 mm 42-641N2023-08-16
icotec AG
VADER Pedicle System, Navigated Cannulated Tap, Ø 6.5 mm 42-631N2023-08-16
icotec AG
VADER Pedicle System, Navigated Cannulated Tap, Ø 5.5 mm 42-621N2023-08-16
icotec AG
VADER Pedicle System, Navigated Cannulated Tap, Ø 4.5 mm 42-611N2023-08-16
icotec AG
VADER Pedicle System, Navigated Pedicle Probe, straight, for 6.5 mm Screw 42-530N2023-08-16
icotec AG
VADER Pedicle System, Navigated Pedicle Probe, straight, for 5.5 mm Screw 42-520N2023-08-16
icotec AG
VADER Pedicle System, Navigated Awl 42-510N2023-08-16
icotec AG
VADER Pedicle System, Navigated Cannulated Polyaxial Screwdriver, T20 42-690N2023-08-16
icotec AG
icotec Cervical Cage, Inserter Rod, long 41-13-52023-05-08
icotec AG
icotec Cervical Cage, Inserter Sleeve, long 41-13-4 2023-05-08
icotec AG
VADER Pedicle System, Cannulated Tap, Ø 7.5 mm 42-6412023-04-04
icotec AG
VADER Pedicle System, Cannulated Tap, Ø 6.5 mm 42-6312023-04-04
icotec AG
VADER Pedicle System, Cannulated Tap, Ø 5.5 mm 42-6212023-04-04
icotec AG
VADER Pedicle System, Cannulated Tap MIS, Ø 7.5 mm 42-6422023-04-04
icotec AG
VADER Pedicle System, Cannulated Tap MIS, Ø 6.5 mm 42-6322023-04-04
icotec AG
VADER Pedicle System, Cannulated Tap MIS, Ø 5.5 mm 42-6222023-04-04
icotec AG
VADER Pedicle System, VADER Pedicle System Rod-2-size, Container Lid 42-890-22023-04-04
icotec AG
VADER Pedicle System, VADER Pedicle System Rod-2-size, Container Base 42-890-12023-04-04
icotec AG
icotec Instrument, Rod Introducer 42-0802023-03-02
icotec AG
icotec instrument, Cervical Cage, Container Lid 41-22-22022-09-06
icotec AG
icotec instrument, Cervical Cage, Container Base 41-22-12022-09-06
icotec AG
icotec instrument, Cervical Cage lordotic, Container, complete 41-222022-09-06
icotec AG
icotec instrument, Lordotic Probe, 8 mm x 16 mm 41-4-08162022-09-06
icotec AG
icotec instrument, Lordotic Probe, 7 mm x 16 mm 41-4-07162022-09-06
icotec AG
icotec instrument, Lordotic Probe, 6 mm x 16 mm 41-4-06162022-09-06
icotec AG
icotec instrument, Lordotic Probe, 5 mm x 16 mm 41-4-05162022-09-06
icotec AG
icotec instrument, Lordotic Probe, 7 mm x 13 mm 41-4-07132022-09-06
icotec AG
icotec instrument, Lordotic Probe, 6 mm x 13 mm 41-4-06132022-09-06
icotec AG
icotec instrument, Lordotic Probe, 5 mm x 13 mm 41-4-05132022-09-06
icotec AG
icotec Cervical Cage, Lordotic, 8 mm x 16 mm 12-40-08162022-09-06
icotec AG
icotec Cervical Cage, Lordotic, 7 mm x 16 mm 12-40-07162022-09-06
icotec AG
icotec Cervical Cage, Lordotic, 6 mm x 16 mm 12-40-06162022-09-06
icotec AG
icotec Cervical Cage, Lordotic, 5 mm x 16 mm 12-40-05162022-09-06
icotec AG
icotec Cervical Cage, Lordotic, 7 mm x 13 mm 12-40-07132022-09-06
icotec AG
icotec Cervical Cage, Lordotic, 6 mm x 13 mm 12-40-06132022-09-06
icotec AG
icotec Cervical Cage, Lordotic, 5 mm x 13 mm 12-40-05132022-09-06
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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