icotec AG

Address:Industriestrasse 12,Altstaetten Sankt Gallen,CH

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Spinal Vertebral Body Replacement Device (MQP) (6) Spinal Vertebral Body Replacement Device - Cervical (PLR) (6) Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (2) Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (2) Thoracolumbosacral Pedicle Screw System (NKB) (2) Bone Cement, Posterior Screw Augmentation (PML) (1)

Premarket Exempt

Clear

icotec Instrument, Pedicle System MIS 2/2, Container, complete - 07640172551271 Catalog Number : 42-862

Device Description : icotec Instrument, Pedicle System MIS 2/2, Container, complete

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KONG-TL VBR System, Extension Rod - 07640172551318 Catalog Number : 44-075

Device Description : KONG-TL VBR System, Extension Rod

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MQP, PLR

Prescription Use : Yes

Device Count : 1

KONG-TL VBR System, Trial Implant, L + ES, Ø 19 mm x 54 mm - 07640172551332 Catalog Number : 44-005-54

Device Description : KONG-TL VBR System, Trial Implant, L + ES, Ø 19 mm x 54 mm

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MQP, PLR

Prescription Use : Yes

Device Count : 1

KONG-TL VBR System, Trial Implant, XL + ES, Ø 19 mm x 60 mm - 07640172551349 Catalog Number :

Device Description : KONG-TL VBR System, Trial Implant, XL + ES, Ø 19 mm x 60 mm

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MQP, PLR

Prescription Use : Yes

Device Count : 1

KONG-TL VBR System, Trial Implant, XL + EM, Ø 19 mm x 75 mm - 07640172551356 Catalog Number : 44-005-75

Device Description : KONG-TL VBR System, Trial Implant, XL + EM, Ø 19 mm x 75 mm

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MQP, PLR

Prescription Use : Yes

Device Count : 1

KONG-C VBR System, Drag Pointer - 07640172551387 Catalog Number : 43-040-1

Device Description : KONG-C VBR System, Drag Pointer

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MQP, PLR

Prescription Use : Yes

Device Count : 1

KONG-TL VBR System, Holding Sleeve - 07640172551394 Catalog Number : 44-010-01

Device Description : KONG-TL VBR System, Holding Sleeve

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MQP, PLR

Prescription Use : Yes

Device Count : 1

icotec Instrument, Inserter Sleeve, long - 07640172551400 Catalog Number : 41-13-4

Device Description : icotec Instrument, Inserter Sleeve, long

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : Yes

Device Count : 1

icotec Instrument, Inserter Rod, long - 07640172551417 Catalog Number : 41-13-5

Device Description : icotec Instrument, Inserter Rod, long

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : Yes

Device Count : 1

VADER Pedicle System, Revision Sleeve - 07640172551424 Catalog Number : 42-441

Device Description : VADER Pedicle System, Revision Sleeve

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : NKB, PML

Prescription Use : Yes

Device Count : 1

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