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icotec AG

Switzerland·CH-MF-000026833

Last updated September 17, 2026

Information

Country: Switzerland
Address: 12, Industriestrasse, Altstätten, Switzerland
Website: www.icotec-medical.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +41717570000
PRRC Contact: Ramon Hüppi
EUDAMED SRN: CH-MF-000026833
FDA FEI Number: 3006493760
DUNS Number: 480789465

Catalogue (355)

Page 2 of 8

Device	Model / Reference	Registries	Class	Status
icotec Lumbar Cage Inserter Handle, ETurn TLIF	38-027	EUDAMEDFDA UDI	Class IIa	Active
VADER® Pedicle System Rod, Carbon/PEEK, Curved Ø 6.0 r120 ↔ 090 mm	16-60-71209	EUDAMEDFDA UDI	Class IIb	Active
VADER® Pedicle System, Rod, Carbon/PEEK, Straight Ø 6.0 r000 ↔ 060 mm	16-60-20006	EUDAMEDFDA UDI	Class IIb	Active
icotec Anterior Cervical Plate System Template for 4-Segmental plate 70 mm	39-18-4-70	EUDAMEDFDA UDI	Class IIa	Active
VADER® Pedicle System Screw, Carbon/PEEK, Polyax., Fen. Ø 7.5 x 40 mm	16-6022-57540	EUDAMEDFDA UDI	Class IIb	Active
icotec Anterior Cervical Plate System Positioning Pin for Template 2.2 mm	39-19-2	EUDAMEDFDA UDI	Class IIa	Active
VADER® Pedicle System Cement Sleeve Container, complete	42-430	EUDAMEDFDA UDI	Class I	Active
icotec Lumbar Cage Probe, PLIF 4°, 13 mm	38-010-413	EUDAMEDFDA UDI	Class IIa	Active
VADER® Pedicle System, Rod, Carbon/PEEK, Curved Ø 6.0 r450 ↔ 160 mm	16-60-24516	EUDAMEDFDA UDI	Class IIb	Active
icotec Lumbar Cage T-Handle	38-025	EUDAMEDFDA UDI	Class I	Active
icotec Anterior Cervical Plate System Template/Fixation Pin Holder SW 4 mm	39-17-1	EUDAMEDFDA UDI	Class IIa	Active
VADER® Pedicle System Rod, Carbon/PEEK, Straight Ø 6.0 r000 ↔ 140 mm	16-60-70014	EUDAMEDFDA UDI	Class IIb	Active
VADER® Pedicle System Navigated Instruments	K230861	FDA 510(k)	Class II	Active
VADER® Pedicle System, G21 Cement	K222789	FDA 510(k)	Class II	Active
VADER® Pedicle System and VADER®one Pedicle System	K242900	FDA 510(k)	Class II	Active
CMORE® CT System; CMORE® CT System Navigated Instruments	K252327	FDA 510(k)	Class II	Active
VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0	K190545	FDA 510(k)	Class II	Active
KONG-TL VBR System, KONG-C VBR System	K200235	FDA 510(k)	Class II	Active
KONG®-TL VBR System and KONG® C VBR System	K232790	FDA 510(k)	Class II	Active
VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0	K193423	FDA 510(k)	Class II	Active
icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn™ TLIF Lumbar Cage)	K232792	FDA 510(k)	Class II	Active
G21 Cement, VADER® Pedicle System	K200596	FDA 510(k)	Class II	Active
icotec Interbody Cage System	K172480	FDA 510(k)	Class II	Active
VADER® Pedicle System Counter Torque Wrench	42-790	EUDAMEDFDA UDI	Class IIa	Active
VADER® Pedicle System T-Handle, Ratchet ¼" Coupling	42-731	EUDAMEDFDA UDI	Class I	Active
icotec Cervical Cage, Cervical Cage, Lordotic, Container, complete	41-22	EUDAMEDFDA UDI	Class I	Active
icotec Lumbar Cage Ring Curette	38-031-00	EUDAMEDFDA UDI	Class IIa	Active
VADER® Pedicle System Tulip Finder Sleeve	42-696	EUDAMEDFDA UDI	Class IIa	Active
icotec Cervical Cage, Anatomic Probe, ↕ 8 mm ↔ 16 mm	41-14-0816	EUDAMEDFDA UDI	Class IIa	Active
VADER® Pedicle System Screw Compressor	42-761	EUDAMEDFDA UDI	Class IIa	Active
VADER® Pedicle System Screw, Carbon/PEEK, Polyax., Fen. Ø 7.5 x 35 mm	16-6022-57535	EUDAMEDFDA UDI	Class IIb	Active
icotec Pedicle System Nut Screw, Ti	16-57-41000	EUDAMEDFDA UDI	Class IIb	Active
VADER® Pedicle System Rod, Carbon/PEEK, Curved Ø 6.0 r450 ↔ 090 mm	16-60-74509	EUDAMEDFDA UDI	Class IIb	Active
VADER® Pedicle System VADER® Pedicle System MIS-2-open Container Lid	42-870-2	EUDAMEDFDA UDI	Class I	Active
icotec Anterior Cervical Plate System Template for 1-Segmental plate 28 mm	39-18-1-28	EUDAMEDFDA UDI	Class IIa	Active
icotec Anterior Cervical Plate System Drill, AO coupling Ø 3mm for 13 mm screw	39-3-13	EUDAMEDFDA UDI	Class IIa	Active
icotec Cervical Cage, Anatomic Probe, ↕ 6 mm ↔ 13 mm	41-14-0613	EUDAMEDFDA UDI	Class IIa	Active
VADER® Pedicle System VADER® Pedicle System 1/2 Container, complete	42-851	EUDAMEDFDA UDI	Class I	Active
VADER® Pedicle System VADER® Pedicle System Cement Sleeve S Container, complete	42-930	EUDAMEDFDA UDI	Class I	Active
icotec Cervical Cage, Inserter Sleeve long, -	41-13-4	EUDAMEDFDA UDI	Class IIa	Active
icotec Lumbar Cage Nerve Root Retractor 10 mm	38-034-10	EUDAMEDFDA UDI	Class IIa	Active
VADER® Pedicle System Trial Rod MIS, curved Ø 6.0 mm, R 120, L = 100 mm	42-910-6010	EUDAMEDFDA UDI	Class IIa	Active
VADER® Pedicle System Rod, Carbon/PEEK, Straight Ø 6.0 r000 ↔ 100 mm	16-60-70010	EUDAMEDFDA UDI	Class IIb	Active
VADER® Pedicle System Trial Rod, curved Ø 5.5 mm, R 450, L = 160 mm	42-911-16	EUDAMEDFDA UDI	Class IIa	Active
VADER® Pedicle System VADER® Pedicle System MIS 2/2 Container, complete	42-862	EUDAMEDFDA UDI	Class I	Active
VADER® Pedicle System Rod, Ti, Straight Ø 6.0 r000 ↔ 060 mm	16-60-80006	EUDAMEDFDA UDI	Class IIb	Active
VADER® Pedicle System Trial Rod, flexible Ø 5.5 mm; L = 200 mm	42-900-5520	EUDAMEDFDA UDI	Class IIa	Active
VADER® Pedicle System, Rod, Carbon/PEEK, Curved Ø 6.0 r450 ↔ 220 mm	16-60-24522	EUDAMEDFDA UDI	Class IIb	Active
VADER® Pedicle System, Rod, Carbon/PEEK, Curved Ø 6.0 r120 ↔ 100 mm	16-60-21210	EUDAMEDFDA UDI	Class IIb	Active
VADER® Pedicle System VADER® Pedicle System Cement Sleeve MIS Container Lid	42-730-2	EUDAMEDFDA UDI	Class I	Active

Related Companies

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icotec Medical GmbH DE

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Icotec US