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

Orthopedic Manual Surgical Instrument (LXH) (5) Thoracolumbosacral Pedicle Screw System (NKB) (3) Tray, Surgical, Instrument (FSM) (2)

Premarket Exempt

No Yes

Clear

KHEIRON - 03701313004958 Catalog Number : 01HH2010

Device Description : Pedicle hook holder

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004965 Catalog Number : 01SH1020

Device Description : Counterhook starter

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004972 Catalog Number : 01SH1010

Device Description : Pedicle hook starter

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004989 Catalog Number : 01BS0115

Device Description : #5 instruments tray - Hooks and iliac extensions

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004996 Catalog Number : 01RK0040

Device Description : Iliac extensions rack

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313005009 Catalog Number : 01CI1010

Device Description : Iliac extensions sizing card

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313005016 Catalog Number : 01DS2030

Device Description : Iliac screwdriver

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313005054 Catalog Number : 25SP55922

Device Description : Left 90° L sacral plate

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313005061 Catalog Number : 25SP55921

Device Description : Right 90° L sacral plate

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313005078 Catalog Number : 25SP55622

Device Description : Left 60° L sacral plate

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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