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

Intervertebral Fusion Device With Bone Graft, Cervical (ODP) (9) Bone Cement, Posterior Screw Augmentation (PML) (1) Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (1) Thoracolumbosacral Pedicle Screw System (NKB) (1)

Premarket Exempt

Clear

icotec Cervical Cage, Lordotic, 7 mm x 13 mm - 07640140430577 Catalog Number : 12-40-0713

Device Description : icotec Cervical Cage, Lordotic, 7 mm x 13 mm

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

icotec Cervical Cage, Lordotic, 5 mm x 16 mm - 07640140430614 Catalog Number : 12-40-0516

Device Description : icotec Cervical Cage, Lordotic, 5 mm x 16 mm

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

icotec Cervical Cage, Lordotic, 6 mm x 16 mm - 07640140430621 Catalog Number : 12-40-0616

Device Description : icotec Cervical Cage, Lordotic, 6 mm x 16 mm

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

icotec Cervical Cage, Lordotic, 7 mm x 16 mm - 07640140430638 Catalog Number : 12-40-0716

Device Description : icotec Cervical Cage, Lordotic, 7 mm x 16 mm

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

icotec Cervical Cage, Lordotic, 8 mm x 16 mm - 07640140430645 Catalog Number : 12-40-0816

Device Description : icotec Cervical Cage, Lordotic, 8 mm x 16 mm

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

icotec Pedicle System, Nut Screw, Ti - 07640140431994 Catalog Number :

Device Description : icotec Pedicle System, Nut Screw, Ti

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : NKB, PML

Prescription Use : Yes

Device Count : 1

icotec Instrument Slotted Hammer - 07640140433363 Catalog Number : 38-7

Device Description : icotec Instrument Slotted Hammer

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : Yes

Device Count : 1

icotec instrument, Lordotic Probe, 5 mm x 13 mm - 07640140433561 Catalog Number : 41-4-0513

Device Description : icotec instrument, Lordotic Probe, 5 mm x 13 mm

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

icotec instrument, Lordotic Probe, 6 mm x 13 mm - 07640140433578 Catalog Number : 41-4-0613

Device Description : icotec instrument, Lordotic Probe, 6 mm x 13 mm

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

icotec instrument, Lordotic Probe, 7 mm x 13 mm - 07640140433585 Catalog Number : 41-4-0713

Device Description : icotec instrument, Lordotic Probe, 7 mm x 13 mm

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

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