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) (10) Spinal Vertebral Body Replacement Device - Cervical (PLR) (10)

Premarket Exempt

Clear

KONG-TL VBR System, Trial Implant, M, Ø 19 mm x 31 mm - 07640172551035 Catalog Number : 44-005-31

Device Description : KONG-TL VBR System, Trial Implant, M, Ø 19 mm x 31 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, L, Ø 19 mm x 35 mm - 07640172551042 Catalog Number : 44-005-35

Device Description : KONG-TL VBR System, Trial Implant, L, Ø 19 mm x 35 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, Ø 19 mm x 41 mm - 07640172551059 Catalog Number : 44-005-41

Device Description : KONG-TL VBR System, Trial Implant, XL, Ø 19 mm x 41 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 Holder - 07640172551097 Catalog Number : 44-005-01

Device Description : KONG-TL VBR System, Trial Implant Holder

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MQP, PLR

Prescription Use : Yes

Device Count : 1

KONG-TL VBR System, Expansion Handle - 07640172551103 Catalog Number : 44-040-01

Device Description : KONG-TL VBR System, Expansion Handle

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : PLR, MQP

Prescription Use : Yes

Device Count : 1

KONG-TL VBR System, Locking Rod - 07640172551110 Catalog Number : 44-040-02

Device Description : KONG-TL VBR System, Locking Rod

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : PLR, MQP

Prescription Use : Yes

Device Count : 1

KONG-TL VBR System, Impact Cap - 07640172551127 Catalog Number : 44-040-03

Device Description : KONG-TL VBR System, Impact Cap

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MQP, PLR

Prescription Use : Yes

Device Count : 1

KONG-TL VBR System, Pusher - 07640172551134 Catalog Number : 44-071

Device Description : KONG-TL VBR System, Pusher

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MQP, PLR

Prescription Use : Yes

Device Count : 1

KONG-TL VBR System, Bone Tamper - 07640172551141 Catalog Number : 44-072

Device Description : KONG-TL VBR System, Bone Tamper

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MQP, PLR

Prescription Use : Yes

Device Count : 1

KONG-TL VBR System, Torque Limiter with Coupling,1/4'' Coupling, 1 Nm - 07640172551165 Catalog Number : 44-074

Device Description : KONG-TL VBR System, Torque Limiter with Coupling, 1/4" Coupling, 1 Nm

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MQP, PLR

Prescription Use : Yes

Device Count : 1

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