icotec AG

Address:Industriestrasse 12,Altstaetten Sankt Gallen,CH

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Filters

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) (5) Spinal Vertebral Body Replacement Device - Cervical (PLR) (5) Thoracolumbosacral Pedicle Screw System (NKB) (5) Bone Cement, Posterior Screw Augmentation (PML) (3)

Premarket Exempt

Clear

VADER Pedicle System MIS-2-open, Container Base - 07640172551448 Catalog Number : 42-870-1

Device Description : VADER Pedicle System MIS-2-open, Container Base

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : NKB, PML

Prescription Use : Yes

Device Count : 1

VADER Pedicle System MIS-2-open, Container Lid - 07640172551455 Catalog Number : 42-870-2

Device Description : VADER Pedicle System MIS-2-open, Container Lid

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : NKB, PML

Prescription Use : Yes

Device Count : 1

VADER Pedicle System MIS-2-open, Container Inlay - 07640172551462 Catalog Number : 42-870-3

Device Description : VADER Pedicle System MIS-2-open, Container Inlay

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : NKB, PML

Prescription Use : Yes

Device Count : 1

KONG-TL VBR System, Revision Forceps - 07640172551479 Catalog Number : 44-076

Device Description : KONG-TL VBR System, Revision Forceps

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MQP, PLR

Prescription Use : Yes

Device Count : 1

KONG-TL VBR System, Adapter for Expansion Handle - 07640172551486 Catalog Number : 44-077

Device Description : KONG-TL VBR System, Adapter for Expansion Handle

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MQP, PLR

Prescription Use : Yes

Device Count : 1

KONG-TL VBR System, KONG-TL VBR E, Container Base - 07640172551493 Catalog Number : 44-090-1

Device Description : KONG-TL VBR System, KONG-TL VBR E, Container Base

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MQP, PLR

Prescription Use : Yes

Device Count : 1

KONG-TL VBR System, KONG-TL VBR E, Container Lid - 07640172551509 Catalog Number : 44-090-2

Device Description : KONG-TL VBR System, KONG-TL VBR E, Container Lid

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MQP, PLR

Prescription Use : Yes

Device Count : 1

KONG-TL VBR System, KONG-TL VBR E, Container Inlay - 07640172551516 Catalog Number : 44-090-3

Device Description : KONG-TL VBR System, KONG-TL VBR E, Container Inlay

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MQP, PLR

Prescription Use : Yes

Device Count : 1

VADER Pedicle System, T-Handle, Ratchet (Push-Mechanism), 1/4" Coupling - 07640172552117 Catalog Number : 42-733

Device Description : VADER Pedicle System, T-Handle, Ratchet (Push-Mechanism), 1/4" Coupling

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

VADER Pedicle System, Palm Handle, Ratchet (Push Mechanism), 1/4 Coupling - 07640172552124 Catalog Number : 42-743

Device Description : VADER Pedicle System, Palm Handle, Ratchet (Push Mechanism), 1/4 Coupling

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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