FDA.report

ICOTEC AG

FDA Registration(s)

RegistrationFEINameStatusInitial importerExpiration yearAddress
30064937603006493760ICOTEC AG1N2026-01-01Industriestrasse 12 Altstaetten Sankt Gallen CH 9450

GUDID Contact Samples

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDIDProductPhoneEmail
07640172552544CMORE® System, Awl - 45-010+41717570000info@icotec.ch
07640172552551CMORE® System, Pedicle Probe, Straight - 45-020+41717570000info@icotec.ch
07640172552568CMORE® System, Drill Guide Sleeve - 45-030+41717570000info@icotec.ch
07640172552575CMORE® System, Drill Guide Stop - 45-030-1+41717570000info@icotec.ch

Registered Device Listings

Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1495311209212249K252327CMORE® CT System; CMORE® CT System Navigated InstrumentsNKG2025-11-12
1495312060556129K242900VADER® Pedicle System and VADER®one Pedicle SystemNKB2025-02-27
1495312010749039K233215icotec Anterior Cervical Plate SystemKWQ2024-05-17
1495311861333401K232792icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)MAX2024-04-05
1495311562652070K232790KONG®-TL VBR System and KONG® C VBR SystemMQP2024-04-04
1495311840453293K232628VADER® Pedicle SystemNKB2024-02-26
1495311318779123K230861VADER® Pedicle System Navigated InstrumentsOLO2023-06-27
1495311917216438K222789VADER® Pedicle System, G21 CementPML2023-01-09
1495311716070457K201587icotec Anterior Cervical Plate SystemKWQ2020-10-15
1495311471939208K200596G21 Cement, VADER® Pedicle SystemPML2020-10-13
1495311062521696K200235KONG-TL VBR System, KONG-C VBR SystemMQP2020-05-29
1495312001659866K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0NKB2020-05-22
1495311058571247K192897icotec Cervical CageODP2020-03-20
1495311461704576K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0NKB2019-06-20
1495311191069418K172480icotec Interbody Cage SystemODP2018-05-17
1495311864753245K122225STERILE RADIOLUCENT SKULL PINSHBL2013-04-26
1495311581908355K111792MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND MINIMAX2012-03-05
1495311265673432

Product Codes Associated With Registrations

Product codeRegistration listing recordsLatest decision
NKB42025-02-27
KWQ22024-05-17
MAX22024-04-05
MQP22024-04-04
PML22023-01-09
ODP22020-03-20
NKG12025-11-12
OLO12023-06-27
HBL12013-04-26

PMN

GUDID

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