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) Pusher, Socket (HXO) (1)

Premarket Exempt

No Yes

Clear

KHEIRON - 03701313000448 Catalog Number : 01PE2010

Device Description : Iliac extension pusher

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : HXO

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000745 Catalog Number : 24PW45025

Device Description : Ø4.5 L25mm pedicle screw

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000752 Catalog Number : 24PW45030

Device Description : Ø4.5 L30mm pedicle screw

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000769 Catalog Number : 24PW45035

Device Description : Ø4.5 L35mm pedicle screw

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000776 Catalog Number : 24PW45040

Device Description : Ø4.5 L40mm pedicle screw

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000783 Catalog Number : 24PW45045

Device Description : Ø4.5 L45mm pedicle screw

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000790 Catalog Number : 24PW45050

Device Description : Ø4.5 L50mm pedicle screw

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000806 Catalog Number : 24PW45055

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000813 Catalog Number : 24PW45060

Device Description : Ø4.5 L60mm pedicle screw

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000837 Catalog Number : 24PW55025

Device Description : Ø5.5 L25mm pedicle screw

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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