S.M.A.I.O

Address:2 Place Berthe Morisot,SAINT-PRIEST Auvergne-Rhone-Alpes,FR

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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

Thoracolumbosacral Pedicle Screw System (NKB) (10)

Premarket Exempt

No Yes

Clear

KHEIRON - 03701313004651 Catalog Number : 28IE56025

Device Description : 25mm iliac extension

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004668 Catalog Number : 28IE56020

Device Description : 20mm iliac extension

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004675 Catalog Number : 26SL00100

Device Description : Large laminar hook

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004682 Catalog Number : 26SL00075

Device Description : Medium laminar hook

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004699 Catalog Number : 26SL00050

Device Description : Small laminar hook

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004705 Catalog Number : 26SP67130

Device Description : Medium, long pedicle hook

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004712 Catalog Number : 26SP67100

Device Description : Medium, short pedicle hook

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004729 Catalog Number : 26SP45130

Device Description : Small, long pedicle hook

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004736 Catalog Number : 26SP45100

Device Description : Small, short pedicle hook

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004743 Catalog Number : 26TC00001

Device Description : Counterhook cap

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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