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) (6) Orthopedic Manual Surgical Instrument (LXH) (4)

Premarket Exempt

No Yes

Clear

KHEIRON - 03701313000202 Catalog Number : 24SR55505

Device Description : Ø5.5 L505mm straight Ti rod

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000219 Catalog Number : 24SR55055

Device Description : Ø5.5 L55mm straight Ti rod

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000226 Catalog Number : 24SR55065

Device Description : Ø5.5 L65mm straight Ti rod

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000233 Catalog Number : 24SR55075

Device Description : Ø5.5 L75mm straight Ti rod

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000240 Catalog Number : 24SR55085

Device Description : Ø5.5 L85mm straight Ti rod

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000257 Catalog Number : 24SR55095

Device Description : Ø5.5 L95mm straight Ti rod

Device Class : 2

Duns Number: 260585710

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000264 Catalog Number : 01RR3010

Device Description : Lateral rod reducer

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000271 Catalog Number : 01HR2040

Device Description : Temporary clip for rod

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000288 Catalog Number : 01HR2030

Device Description : Long curved rod holder

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

KHEIRON - 03701313000295 Catalog Number : 01HR2020

Device Description : Curved rod holder

Device Class : 1

Duns Number: 260585710

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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