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) (10) Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (6)

Premarket Exempt

Clear

icotec instrument, Lordotic Probe, 5 mm x 16 mm - 07640140433622 Catalog Number : 41-4-0516

Device Description : icotec instrument, Lordotic Probe, 5 mm x 16 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 16 mm - 07640140433639 Catalog Number : 41-4-0616

Device Description : icotec instrument, Lordotic Probe, 6 mm x 16 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 16 mm - 07640140433646 Catalog Number : 41-4-0716

Device Description : icotec instrument, Lordotic Probe, 7 mm x 16 mm

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

icotec instrument, Lordotic Probe, 8 mm x 16 mm - 07640140433653 Catalog Number : 41-4-0816

Device Description : icotec instrument, Lordotic Probe, 8 mm x 16 mm

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : ODP

Prescription Use : Yes

Device Count : 1

icotec Instrument, Cervical Cage anatomic, Container, complete - 07640140433783 Catalog Number : 41-12

Device Description : icotec Instrument, Cervical Cage anatomic, Container, complete

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : Yes

Device Count : 1

icotec Instrument, Cervical Cage anatomic, Container Base - 07640140433790 Catalog Number : 41-12-1

Device Description : icotec Instrument, Cervical Cage anatomic, Container Base

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : Yes

Device Count : 1

icotec Instrument, Cervical Cage anatomic, Container Lid - 07640140433806 Catalog Number : 41-12-2

Device Description : icotec Instrument, Cervical Cage anatomic, Container Lid

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : Yes

Device Count : 1

icotec Instrument Anatomic Probe 5 x 13 mm - 07640140433813 Catalog Number : 41-14-0513

Device Description : icotec Instrument Anatomic Probe 5 x 13 mm

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : Yes

Device Count : 1

icotec Instrument Anatomic Probe 6 x 13 mm - 07640140433820 Catalog Number : 41-14-0613

Device Description : icotec Instrument Anatomic Probe 6 x 13 mm

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : Yes

Device Count : 1

icotec Instrument Anatomic Probe 7 x 13 mm - 07640140433837 Catalog Number : 41-14-0713

Device Description : icotec Instrument Anatomic Probe 7 x 13 mm

Device Class : 2

Duns Number: 480789465

Premarket Exempt : No

Product Code : MAX, ODP

Prescription Use : Yes

Device Count : 1

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