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) (9)

Premarket Exempt

No Yes

Clear

KHEIRON - 03701313005085 Catalog Number : 25SP55621

Device Description : Right 60° L sacral plate

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313005092 Catalog Number : 25SN55006

Device Description : S2 screw L securing cap

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313005108 Catalog Number : 25SN55024

Device Description : L Sacral plate nut

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313005115 Catalog Number : 25SC60023

Device Description : Ø6 rod L sacral connector

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313005122 Catalog Number : 25SC55023

Device Description : Ø5.5 rod L sacral connector

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313005139 Catalog Number : 24PW56635

Device Description : Large, closed derotation offset connector

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313005146 Catalog Number : 24PW56630

Device Description : Small, closed derotation offset connector

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313005153 Catalog Number : 24PW56625

Device Description : Large, open derotation offset connector

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313005160 Catalog Number : 24PW56620

Device Description : Small, open derotation offset connector

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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