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) Tray, Surgical, Instrument (FSM) (4) Thoracolumbosacral Pedicle Screw System (NKB) (1)

Premarket Exempt

No Yes

Clear

KHEIRON - 03701313004859 Catalog Number : 26PH45100

Device Description : Small, short claw pedicle hook

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004866 Catalog Number : 01RK0053

Device Description : Pedicle - laminar hooks rack

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004873 Catalog Number : 01RK0052

Device Description : Right counterhooks rack

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004880 Catalog Number : 01RK0051

Device Description : Left counterhooks rack

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004897 Catalog Number : 01RK0050

Device Description : Claw pedicle hooks rack

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : FSM

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004903 Catalog Number : 01DN5010

Device Description : Angled revision nut driver

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004910 Catalog Number : 01CH3010

Device Description : Claw compressor

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004927 Catalog Number : 01PS3010

Device Description : Counterhook rod pusher

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004934 Catalog Number : 01HH2030

Device Description : Laminar hook holder

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313004941 Catalog Number : 01HH2020

Device Description : Counterhook holder

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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